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

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.

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Key information

Conditions

Patient Satisfaction Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Preoperative Anxiety Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shaukat Khanum memorial cancer hospital and research centre

Lahore, 536500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 70 years of age.
Known cases of Breast Cancer.
Undergoing Breast Surgery as a part of treatment.
Availability of Personal smart phone at home.
Written informed Consent given for participation in trial.
Females.

Exclusion criteria

Less than 18 years or more than 70 years of age.
Stage IV patients undergoing palliative breast surgery.
Patient having chronic pain.
Un-availability of smart phone.
Patients with known psychiatric/depression disorders.
Previous history of another treated carcinoma.
Patients with re-current breast carcinoma.
Male Patients are excluded from study.

Treatment and study plan

comprehensive educational program for reduction of Pre-Operative Anxiety

Other

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.

Other names: Breast Surgery Education Package 1 (BSEP 1)

Primary outcomes

Patient Pre-Operative Anxiety

Time frame: 6 months

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.

Secondary outcomes

Patient Satisfaction.

Time frame: 6 Months

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.

Sponsors and collaborators

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Other

Registry information

Acronym: PAUSDE

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 5, 2023
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed