The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Randomizer.org website was used for randomization of the research sample. It consists of four rooms, patient room numbers 634, 635, 636 and 637. The room numbers obtained during randomization were assigned to the 1st group intervention (21 cases of open abdominal surgery) and the 2nd group to the control group (21 cases of open abdominal surgery) by simple random method. By entering the room numbers into two unique sets, patients sleeping in the rooms in the 1st set (634-636) and meeting the inclusion criteria were included in the intervention group. Patients sleeping in the rooms in the 2nd set (635-637) and meeting the inclusion criteria were included in the control group. was included in the group. In the study, each patient was included in the research group after informed consent was obtained. In case of refusal, consent was obtained from the next patient in the room and the process of obtaining consent was continued until the number of samples was completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Readmission due to any complications that develop after discharge,
- •Having visual, hearing and speech disabilities
研究组 & 干预措施
Control group
After the patient was mobilized on the zero postoperative day, STAI-I and VAS were applied 1 hour apart. VAS was repeated every 4 hours until the patient was discharged.
- On the first day after surgery, VAS with STAI-I was applied to the patient every 1 hour after breakfast, and VAS was repeated every 4 hours during the day.
- On the second day after the surgery, STAI-I and VAS were applied to the patient 1 hour apart after breakfast.
- On the second postoperative day, the Postoperative Period Patient Evaluation form was applied to the patient before discharge.
Intervention group (Mandala activity)
Mandala activity is painting with different pictures or shapes by creating a harmony of figures in different or the same colors. The entire intervention group was given a booklet consisting of 10 simple mandala drawings prepared by the researchers. Mandala activity: During the hospital stay on the zeroth, first and second postoperative days, the patient was asked to color the mandala drawing of his choice from the booklet as many times as he wanted. However, they were asked to practice at least one mandala activity every day. For painting in the mandala activity, a set of 12 colored crayons was given to the patients by the researcher and no color guidance was given for painting. The research was continued by following up within 3 days, namely the zeroth, first and second postoperative days. VAS and STAI-I forms were applied before and after the mandala activity.
干预措施: mandala activity (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 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.
次要结局
- Number of analgesia use(1 February 2023 - 1 August 2023 (6 months or 182 days))
研究者
Ayça Demir Yıldırım, PhD
Assistant Professor, PhD, Lecturer
Istanbul University - Cerrahpasa (IUC)