NCT07160062

Brief Summary

Aim: The aim of this study was to investigate the effect of mandala painting on psychological well-being, emotional self-efficacy, and anxiety in gynecological cancer patients during the perioperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

5 days

First QC Date

August 30, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

Emotional Self-Efficacy

Outcome Measures

Primary Outcomes (3)

  • Emotional Self-Efficacy Scale

    The Turkish adaptation of the scale developed by Kirk, Shutte, and Hine was conducted by Totan, İkiz, and Karaca. The scale consists of 32 items and is based on a 5-point Likert scale (1-Strongly disagree, 7-Strongly agree).

    change from before implamentation patent and after 1st and 3rd days of practice

  • Psychological Well-Being Scale

    The scale was developed by Diener et al. to integrate and complement psychological well-being data and to measure social and psychological well-being. The Psychological Well-Being Scale was adapted into Turkish by Telef. The Cronbach's Alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80. The Psychological Well-Being Scale consists of 8 items.

    change from before implamentation patent and after 1st, and 3rd day of practice

  • State Anxiety Scale

    The State and Trait Anxiety Scale, developed by Spielberger et al., was adapted into Turkish by Öner and Le Compte. It consists of two sections, each containing 20 questions. The questions in the State Anxiety Scale (SAS), which measures short-term anxiety arising from a temporary dangerous situation, are on a 4-point Likert scale (1: Not at all, 2: A little, 3: Very much, 4: Completely).

    change from before implamentation patent and after 1st and 3rd days of practice

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Mandala painting

Control group

NO INTERVENTION

Interventions

Each mandala painting process took a total of 35 to 50 minutes, consisting of 30 to 40 minutes for mandala painting and drawing and 5 to 10 minutes for explaining the painted mandala.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • Diagnosed with any type or stage of gynecological cancer,
  • In the perioperative period and scheduled for surgery,
  • Willing to participate in this intervention,
  • With written consent,
  • Volunteering to participate in the study

You may not qualify if:

  • Those with a serious physical or mental illness,
  • Those with intellectual or cognitive impairment,
  • Those with serious perioperative medical complications,
  • Those who withdrew or dropped out of the study early,
  • Those who were not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-BeingAnxiety Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 8, 2025

Study Start

May 20, 2025

Primary Completion

May 25, 2025

Study Completion

August 26, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations