Clinical trial NCT06590389: The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
Official title: The Effect Of Mandala Activity On Postoperative Pain And Anxiety Levels In Gynecological Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Pain
Cancer, Treatment-Related
Cancer
Keywords: pain
anxiety
midwife
Gynecological Oncology
mandala
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
Secondary outcomes:
measure: Number of analgesia use
timeFrame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
Other outcomes:
measure: State-Trait Anxiety Inventory I (STAI-I)
timeFrame: 1 February 2023 - 1 August 2023 (6 months or 182 days)
Locations:
city: Istanbul
country: Turkey
facility: Üsküdar University
state: Üsküdar
Study officials:
affiliation: https://uskudar.edu.tr/akademik-personel/ayca-demir-yildirim
name: Ayça Demir Yıldırım, Phd
role: STUDY_DIRECTOR
References:
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