Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial

Anxiety Clinical Trial

— PAUSDE  

Official title:

Reduction of Pre-operative Anxiety Using a Specially Designed Educational Program for Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05887856
• Other study ID #: IRB-22-40
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: June 2023
• Source: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to find out that if a specially designed educational program can help in reduction of pre-operative anxiety in breast cancer patients undergoing surgery as a part of their treatment.

Description:

Anxiety can be defined as an unpleasant subjective experience associated with the perception of real threat; therefore, it is a common symptom in connection with cancer. Breast Cancer patients undergo surgery at some stage of their treatment, Surgery details can be overwhelming and might lead to low retention of information and greater levels of anxiety which is the most prevalent psychological symptoms perceived by cancer patients.

Studies have shown women with a diagnosis of cancer correlate with higher levels of preoperative anxiety. Increased anxiety elicits physiologic stress responses that may impede healing and alter responses to postoperative pain.It can also lead to delayed recovery, prolonged hospital stay and increased need of postoperative pain medications.

Pre-Operative Anxiety may also cause delayed recovery from Anesthesia and can also compromise the effectiveness of anesthesia .Furthermore, it can lead to other post-operative complications such as nausea, vomiting, and delayed wound healing. Various Pharmacological and non-pharmacological methods have been used for reduction of pre-operative anxiety and one such non-pharmacological method is educating the patients about the experience of surgery pre-operatively which we aim to study in our population.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18 to 70 years of age.

2. Known cases of Breast Cancer.

3. Undergoing Breast Surgery as a part of treatment.

4. Availability of Personal smart phone at home.

5. Written informed Consent given for participation in trial.

6. Females.

Exclusion Criteria:

1. Less than 18 years or more than 70 years of age.

2. Stage IV patients undergoing palliative breast surgery.

3. Patient having chronic pain.

4. Un-availability of smart phone.

5. Patients with known psychiatric/depression disorders.

6. Previous history of another treated carcinoma.

7. Patients with re-current breast carcinoma.

8. Male Patients are excluded from study.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Patient Satisfaction
• Preoperative Anxiety

Intervention

Other:
• comprehensive educational program for reduction of Pre-Operative Anxiety
BSEP 1 makes use of modern media and aims to educate patients and their carers through educational videos comprising of various aspect of surgical treatment. Introduction to surgery by consultant surgeon, Patient to receive video of their own surgeon. Introduction to Anesthesia. What are different type of breast surgeries in cancer patients (General Video) Specific video pertaining to the type of surgery patient is undergoing (Mastectomy, Breast Conserving Surgery, Breast Re Construction surgery) Explanation of Methicillin-resistant Staphylococcus aureus Decolonization protocol What to expect on Surgery Day Virtual tour of Holding bay and Operation Room Post-Operative care including wound care, drain management and common post-operative complications.

Locations

Country	Name	City	State
Pakistan	Shaukat Khanum memorial cancer hospital and research centre	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Shaukat Khanum Memorial Cancer Hospital & Research Centre

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Ahlberg K, Ekman T, Wallgren A, Gaston-Johansson F. Fatigue, psychological distress, coping and quality of life in patients with uterine cancer. J Adv Nurs. 2004 Jan;45(2):205-13. doi: 10.1046/j.1365-2648.2003.02882.x. — View Citation

Aviado-Langer J. Measuring preoperative anxiety in patients with breast cancer using the visual analog scale. Clin J Oncol Nurs. 2014 Oct;18(5):489-91. doi: 10.1188/14.CJON.489-491. — View Citation

Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and contributing factors. Can J Anaesth. 1990 May;37(4 Pt 1):444-7. doi: 10.1007/BF03005624. — View Citation

Boeke S, Duivenvoorden HJ, Verhage F, Zwaveling A. Prediction of postoperative pain and duration of hospitalization using two anxiety measures. Pain. 1991 Jun;45(3):293-297. doi: 10.1016/0304-3959(91)90053-Z. — View Citation

Granziera E, Guglieri I, Del Bianco P, Capovilla E, Dona' B, Ciccarese AA, Kilmartin D, Manfredi V, De Salvo GL. A multidisciplinary approach to improve preoperative understanding and reduce anxiety: a randomised study. Eur J Anaesthesiol. 2013 Dec;30(12):734-42. doi: 10.1097/EJA.0b013e3283652c0c. — View Citation

Takahashi T, Hondo M, Nishimura K, Kitani A, Yamano T, Yanagita H, Osada H, Shinbo M, Honda N. Evaluation of quality of life and psychological response in cancer patients treated with radiotherapy. Radiat Med. 2008 Aug;26(7):396-401. doi: 10.1007/s11604-008-0248-5. Epub 2008 Sep 4. — View Citation

Vileikyte L. Stress and wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):49-55. doi: 10.1016/j.clindermatol.2006.09.005. — View Citation

Zhang C, Liu X, Hu T, Zhang F, Pan L, Luo Y, Wang Z. Development and psychometric validity of the perioperative anxiety scale-7 (PAS-7). BMC Psychiatry. 2021 Jul 16;21(1):358. doi: 10.1186/s12888-021-03365-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Pre-Operative Anxiety	This will be measured by using The Perioperative Anxiety Scale-7 (PAS-7), PAS 7 is a validated tool which includes seven items. This tool was developed by Zhang, C., Liu, X., Hu, T. et al. at Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.; Permissions were obtained and granted for use of PAS 7 in this project and its translation into Urdu. The process of translation involved forward translation by two independent translators, formation of a reconciled version by third translator, Back translation, independent review and finalization.	6 months
Secondary	Patient Satisfaction.	This will be measured using Patient satisfaction questionnaire Short Form (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items comprising of General satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience. PSQ-18 is a free to use validated tool developed by RAND Corporation. The translation of the tool is allowed by the RAND Corporation with precise instructions regarding the translation process. These instructions were followed while translating the tool. The process of translation involved forward translation by two independent translators, formation of a reconciled version by third translator, Back translation, independent review and finalization.	6 Months

External Links

•   Rand.org. 2022. Basic Guide for Translating Surveys.