Breast Cancer Clinical Trial
— LymphLightOfficial title:
Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | February 2028 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with breast cancer - Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection - Underwent radiotherapy with or without chemotherapy - Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher) - Age = 18 years - Able to comply to the study protocol - Able to sign written informed consent Exclusion Criteria: - Metastatic disease - Pregnancy - History of surgery or trauma to the arm - History of arm infection in the past 3 months - Use of medications that affect body fluid (e.g., diuretics) in the last 3 months - Severe psychological disorder or dementia - Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator |
Country | Name | City | State |
---|---|---|---|
Belgium | Hasselt University | Hasselt | Limburg |
Belgium | Jessa Ziekenhuis | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital | Hasselt University |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | Baseline | |
Other | General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | 3 month follow-up | |
Other | General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | 6 month follow-up | |
Other | General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | 9 month follow-up | |
Other | General patient-, disease-, and treatment-related information | General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage). | 12 month follow-up | |
Other | Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 12 month follow-up | |
Other | Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 2 years follow up | |
Other | Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 3 years follow up | |
Other | Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 4 years follow up | |
Other | Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 5 years follow up | |
Other | Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 1 year follow up | |
Other | Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 2 years follow up | |
Other | Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 3 years follow up | |
Other | Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 4 years follow up | |
Other | Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 5 years follow up | |
Other | Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 1 year follow up | |
Other | Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 2 years follow up | |
Other | Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 3 years follow up | |
Other | Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 4 years follow up | |
Other | Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 5 years follow up | |
Other | Date of death of any cause | If the patient dies within the first year after the treatment, their date of death will be collected. | 1 year follow up | |
Other | Date of death of any cause | If the patient dies within 2 years after the treatment, their date of death will be collected. | 2 years follow up | |
Other | Date of death of any cause | If the patient dies within 3 years after the treatment, their date of death will be collected. | 3 years post treatment | |
Other | Date of death of any cause | If the patient dies within 4 years after the treatment, their date of death will be collected. | 4 years follow up | |
Other | Date of death of any cause | If the patient dies within 5 years after the treatment, their date of death will be collected. | 5 years follow up | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
Baseline | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
week 5 | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
week 9 | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
Week 14 | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
Week 18 | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
3 month follow-up | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
6 month follow-up | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
9 month follow-up | |
Primary | Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12p C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter |
12 month follow-up | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | Baseline | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 5 | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 9 | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 14 | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 18 | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 3 month follow-up | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 6 month follow-up | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 9 month follow-up | |
Primary | Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 12 month follow-up | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. | Baseline | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 5 | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 9 | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 14 | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 18 | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 3 month follow-up | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 6 month follow-up | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 9 month follow-up | |
Primary | Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 12 month follow-up | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Baseline | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Week 9 | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Week 18 | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 3 month follow-up | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 6 month follow-up | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 9 month follow-up | |
Primary | ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 12 month follow-up | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | Baseline | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 5 | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 9 | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 14 | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 18 | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 3 month follow-up | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 6 month follow-up | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 9 month follow-up | |
Secondary | Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 12 month follow-up | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | Baseline | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 5 | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 9 | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 14 | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 18 | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 3 month follow-up | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 6 month follow-up | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 9 month follow-up | |
Secondary | Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 12 month follow-up | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | Baseline | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 5 | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 9 | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 14 | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 18 | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). | 3 month follow-up | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 6 month follow-up | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 9 month follow-up | |
Secondary | Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 12 month follow-up | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | At week 9 | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | At week 18 | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 3 month follow-up | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 6 month follow-up | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 9 month follow-up | |
Secondary | Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 12 month follow-up |
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