The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

Pain, Postoperative Clinical Trial

Official title:

The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708872
• Other study ID #: NIOCHIR 01/22
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Marta Nowak-Kulpa
• Phone: +48 322788417
• Email: Marta.Nowak-Kulpa[@]io.gliwice.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, it will be investigated whether the methods of self-regulation of mental state have an effect on postoperative pain perception in colon cancer patients.

Description:

According to the assumptions of psychoneuroimmunology, the improvement of mental state affects the physical improvement of patients. Numerous studies confirm the effectiveness of hypnosis and learning autohypnosis in improving the functioning of patients in terms of reducing pain and anxiety, improving the quality of sleep and mood. The study is a Prospective Randomized Controlled Trial consisting of two groups. Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state. Patients in the control group will receive a recording with relaxing music. Depending on the randomization, patients will listen to the selected recording before being admitted to the surgical department. They will then be given a recording to listen to whenever they want. The patients will be examined four times using the Activity Change Scale, ie. before randomization, on the first day after surgery, on the 7th day after surgery and 1 month after surgery. Simultaneously the total analgesic consumption will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent to participate in the study

2. Age >= 18 years

3. Histopathological diagnosis of primary colon cancer without distant metastasis

4. Planned surgical treatment

5. Fluency in Polish

Exclusion Criteria:

1. Severe comorbidities with pain disorders

2. Regular use of analgesics

3. Coexistence of another neoplastic disease

4. Use of non-pharmacological pain management (including autohypnosis) prior to the study

5. Poor general condition

6. Previous colorectal surgery

7. Hearing disorders

8. No possibility of playback of the received recording

Related Conditions & MeSH terms

• Colonic Neoplasms
• Hypnotherapy
• Neoplasms
• Pain, Postoperative

Intervention

Behavioral:
• Autohypnosis
Patients in the study group will receive a voice recording with hypnotic instructions with a suggestion to improve the psychophysical state.
• Relaxing music
Patients in the control group will receive a recording with relaxing music

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch	Gliwice

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of methods of self-regulation of mental state on postoperative pain perception changes	The timing of primary outcome measurement includes more than one time point because outcome measurements assess changes in patient status.; The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale.; For pain, the score will be reviewed by asking: 1. Which bodily sensations predominate at the site of the illness? A score of -10 indicates maximal relief; 0 neutral condition; and +10 indicates maximal pain.; For all answers, higher scores mean a worse outcome.	The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.
Secondary	Effect of methods of self-regulation of mental state on mood changes	The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status.; The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale.; In terms of mood, the grade will be assessed using the following questions: 1. What mood is prevalent? A score of -10 means a maximal increase in mood; 0 state as usual (no change); and +10 means maximal state lowered.; For all answers, higher scores mean a worse outcome.	The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.
Secondary	Effect of methods of self-regulation of mental state on anxiety changes	The timing of secondary outcome measurement includes more than one time point because outcome measurements assess changes in patient status.; The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery. The measure will assess the condition over the last 24 hours on scales ranging from -10 to +10 of the Activity Change Scale.; In terms of anxiety, the grade will be assessed using the following questions: What is the level of anxiety? A score of -10 means maximal calm; 0 state as usual (no change); and +10 means maximal high anxiety.; How do you feel about the future? A score of -10 means maximum hope that things are going to work out; 0 status as usual (no change); and +10 means maximum anxiety about the future.; For all answers, higher scores mean a worse outcome.	The patient's condition will be assessed before surgery and at the following post-operative periods: the first day, the fourth day and one month after surgery.