NCT05283460

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

February 7, 2022

Last Update Submit

March 18, 2022

Conditions

Keywords

Gynecologic CancerLife satisfactionMandala

Outcome Measures

Primary Outcomes (1)

  • Life satisfaction scale mean

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

    up to 3 weeks

Secondary Outcomes (1)

  • Life satisfaction scale mean

    through study completion, an average of 1 year

Study Arms (2)

mandala

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

mandalaBEHAVIORAL

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.

Also known as: control group
mandala

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBecause gynecological cancers occur only in women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving chemotherapy
  • No communication problems
  • Having at least 6 months of cancer diagnosis
  • Being in Stage 2 and Stage 3 of the disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University

Tunceli, Merkez, 62002, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nursel A Dal, Assist Prof

    Munzur Ünivesitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
participants will not known wich type of group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was designed as a randomized controlled prospective double-blind clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 17, 2022

Study Start

June 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations