The Effect of Mandala Activity on Life Satisfaction

Sponsor
Munzur University (Other)
Overall Status
Completed
CT.gov ID
NCT05283460
Collaborator
(none)
60
1
2
7
8.6

Study Details

Study Description

Brief Summary

This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mandala
N/A

Detailed Description

Data will be collected using the descriptive information form and the Life Satisfaction Scale.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study was designed as a randomized controlled prospective double-blind clinical trial.This study was designed as a randomized controlled prospective double-blind clinical trial.
Masking:
Double (Participant, Care Provider)
Masking Description:
participants will not known wich type of group
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: mandala

As in the case of previous studies, to prevent confusion and make the mandala drawing process easier, a few videos describing what a mandala is were shown to the patients, and information was provided. Next, each patient was given a set of felt-tip pens (in 24 different colors) and ready-to-use mandala papers, and they were asked to complete the mandala activity. The patients were given empty mandala books with enough pages for them to draw mandalas every day, they were asked to perform the mandala activity regularly in a time interval of their own choice every day, and whether they performed the activity was checked daily without them noticing (so that they would not have the feeling of being checked on or inspected).

Behavioral: mandala
The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.
Other Names:
  • control group
  • No Intervention: control group

    The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.

    Outcome Measures

    Primary Outcome Measures

    1. Life satisfaction scale mean [up to 3 weeks]

      Average score from life satisfaction scale ( Minimum score; 5, Maximum score;25)

    Secondary Outcome Measures

    1. Life satisfaction scale mean [through study completion, an average of 1 year]

      Average score from life satisfaction scale( Minimum score;5 , Maximum score;25)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Receiving chemotherapy

    • No communication problems

    • Having at least 6 months of cancer diagnosis

    • Being in Stage 2 and Stage 3 of the disease

    Exclusion Criteria:
    • Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.

    • Being in Stage 1 and Stage 4 of the disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Munzur University Tunceli Merkez Turkey 62002

    Sponsors and Collaborators

    • Munzur University

    Investigators

    • Principal Investigator: Nursel A Dal, Assist Prof, Munzur Ünivesitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nursel Alp Dal, Principal Investigator, Munzur University
    ClinicalTrials.gov Identifier:
    NCT05283460
    Other Study ID Numbers:
    • munzur u
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nursel Alp Dal, Principal Investigator, Munzur University

    Study Results

    No Results Posted as of Mar 31, 2022