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Completed

NCT Number: NCT06590389

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

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.

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Key information

Conditions

Cancer Pain Anxiety Disorders Cancer Cancer, Treatment-Related Mental Disorders Neoplasms Neoplasms, Second Primary Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar University

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mandala activity

Other

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.

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Number of analgesia use

    Time frame: 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 outcomes

  1. State-Trait Anxiety Inventory I (STAI-I)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Oct 1, 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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