Cancer Pain, Cancer, Treatment-Related, Cancer
Conditions
Keywords
pain, anxiety, midwife, Gynecological Oncology, mandala
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.
Interventions
OTHERmandala activity
A descriptive patient form, VAS and STAI-I were applied before surgery. After the surgery, VAS and STAI-I were applied before and after the mandala activity until the patient was discharged. The VAS form was applied every 4 hours until the patient was discharged. This process was repeated in the same way for the entire intervention group.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory I (STAI-I) | 1 February 2023 - 1 August 2023 (6 months or 182 days) | The scale measures state and trait anxiety as Likert scale with 20 separate questions. The higher the scores, the higher the level of anxiety and the lower the scores, the lower the level of anxiety. The total score of both scales ranges from a minimum of 20 to a maximum of 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety. |
Countries
Turkey (Türkiye)
Outcome results
None listed