The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients

Not Applicable

Completed

• Conditions: Cancer Pain; Cancer, Treatment-Related; Cancer

• Registration Number: NCT06590389
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.

Detailed Description

This study was designed as a randomised controlled, 2-group, pre-test post-test comparative, experimental study to examine the effect of mandala activity on postoperative pain, anxiety levels and analgesia use of gynaecological oncology patients.

The study was conducted with 42 patients who underwent open abdominal hysterectomy surgery in the Gynecological Oncology Surgery Clinic of a training and research hospital in Istanbul between 1 February 2023 and 1 August 2023. Patients in the intervention group (n=21) received mandala activity at least once a day during their postoperative hospitalisation (days 0-2). Patients in the control group (n=21) did not receive any intervention. Introductory Information Form, Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Postoperative Patient Evaluation Form and Mandala Activity Booklet were used in the study.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-08-01
• Study First Submitted: 2024-07-07
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• Having a gynecological oncology disease diagnosis,
• Having had open abdominal hysterectomy surgery,
• Being over 18 years of age,
• Ability to communicate in Turkish,
• Having a gynecological oncology operation for the first time,
• There is no physical disability related to the upper extremities.

Exclusion Criteria

• Readmission due to any complications that develop after discharge,
• Having visual, hearing and speech disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	1 February 2023 - 1 August 2023 (6 months or 182 days)	This scale is used to visually assess and then quantify values that cannot be measured quantitatively. It was used to measure the pain intensity of gynecologic oncology patients in both the intervention and control groups. In this scale, the variable to be evaluated is written on both ends of a 100 mm long line. The patient was asked to place a line, dot or cross on this beam by asking which one she was closer to. For example, the leftmost part is labeled "no pain" and the other end is labeled "most severe pain". The patient makes a mark on the ray according to his/her current condition. Starting from the left end, i.e. where there is no pain at all, the part up to the point where the patient has pain, i.e. where the patient makes a mark, is measured. This quantity indicates the intensity of the patient's pain. The increase in quality and quantity indicates an increase in pain intensity.

Secondary Outcome Measures

Name	Time	Method
Number of analgesia use	1 February 2023 - 1 August 2023 (6 months or 182 days)	It is a form used to evaluate the use of postoperative analgesia in gynaecological oncology patients.

Trial Locations

Locations (1)

Üsküdar University; 🇹🇷 Istanbul, Üsküdar, Turkey