NCT07788508

Brief Summary

Midwives working in delivery rooms are exposed to occupational and psychological stressors associated with high workloads, shift work, time pressure, obstetric emergencies, and traumatic perinatal events. These working conditions may adversely affect their psychological resilience and well-being. Mandala coloring is a simple, low-cost, art-based activity that may promote relaxation and psychological well-being; however, evidence regarding its effect on psychological resilience among midwives is limited. The aim of this study was to evaluate the effect of mandala coloring on psychological resilience among midwives working in delivery rooms. Secondary outcomes included depression, anxiety, stress, and psychological well-being. The study was conducted as a two-arm, pretest-posttest, matched cluster randomized controlled trial involving midwives working in the delivery rooms of eight hospitals. Hospitals were treated as clusters and matched into four pairs according to the number of midwives working in the delivery room and the annual number of births. Within each matched pair, one hospital was randomly assigned to the intervention group and the other to the control group. A total of 91 midwives participated in the study, with 45 midwives from four hospitals allocated to the intervention group and 46 midwives from four hospitals allocated to the control group. Midwives in the intervention group participated in a six-week mandala coloring program. They were asked to complete two mandala coloring sessions per week, for a total of 12 sessions, with each session lasting approximately 20-30 minutes. Participants in the control group continued their usual routines during the six-week study period. Psychological resilience was assessed as the primary outcome using the Resilience Scale for Adults. Depression, anxiety, and stress were assessed using the Depression Anxiety Stress Scale-21, and psychological well-being was assessed using the Psychological Well-Being Scale. Outcomes were assessed at baseline and at the end of the six-week intervention period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

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

January 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

August 23, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

Psychological resilienceMandala coloringMidwivesDelivery roomdepressionanxietystress

Outcome Measures

Primary Outcomes (1)

  • Resilience Scale for Adults (RSA)

    Psychological resilience was assessed using the Resilience Scale for Adults (RSA). The scale consists of 33 items and yields a total score ranging from 33 to 165. Higher scores indicate higher levels of psychological resilience. The primary outcome was the change in the total RSA score from baseline to the end of the six-week intervention.

    Baseline and immediately after the 6-week intervention

Secondary Outcomes (2)

  • Depression Anxiety Stress Scale-21 (DASS-21)

    Baseline and immediately after the 6-week intervention

  • Psychological Well-Being Scale

    Baseline and immediately after the 6-week intervention

Study Arms (2)

Mandala Coloring Group

EXPERIMENTAL

Participants in this arm completed a six-week mandala coloring intervention. They were instructed to color a mandala twice per week for approximately 20-30 minutes per session, resulting in a total of 12 planned sessions. Participants selected a mandala design and colored it according to their own preferences. Adherence was monitored by asking participants to notify the researcher before each session and to send a photograph of the completed mandala after each session. Reminder messages were sent twice weekly.

Behavioral: Mandala Coloring

Control Group

NO INTERVENTION

Participants in this arm continued their usual routines and did not receive the mandala coloring intervention during the six-week study period. They were contacted twice weekly to determine whether they had engaged in any relaxation or stress-reducing activities during the study period. After completion of the final assessment, participants were provided with information about mandala coloring and were offered the opportunity to engage in the activity.

Interventions

Participants completed mandala coloring twice per week for six consecutive weeks, for a total of 12 sessions. Each session lasted approximately 20-30 minutes and was conducted during working hours at a time suitable for the participant. Participants selected one of the provided mandala designs and colored it according to their own preferences using a 12-color felt-tip pen set. Adherence was monitored through messages sent before each session and photographs of the completed mandalas sent to the researcher after each session. Reminder messages were sent twice weekly.

Mandala Coloring Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Working as a midwife in the delivery room of one of the participating hospitals
  • Voluntarily agreeing to participate in the study
  • Providing informed consent

You may not qualify if:

  • Having difficulty communicating in Turkish or having a hearing, speech, or comprehension impairment that could interfere with communication and participation in the study
  • Having a physical or visual impairment that could prevent participation in the mandala coloring activity
  • Having a psychiatric disorder
  • Routinely engaging in stress-reduction or relaxation practices, such as meditation or yoga

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medipol Bahçelievler Üniversity Hospital

Istanbul, Bahçelievler, Turkey (Türkiye)

Location

Medipol Mega Üniversity Hospital

Istanbul, Bağcılar, Turkey (Türkiye)

Location

Medipol Esenler Üniversity Hospital

Istanbul, Esenler, Turkey (Türkiye)

Location

MEDIPOL Acıbadem Regional Hospital

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Medipol Koşuyolu Hospital

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Medipol Sefaköy Üniversity Hospital

Istanbul, Küçükçekmece, Turkey (Türkiye)

Location

Medipol Pendik Üniversity Hospital

Istanbul, Pendik, Turkey (Türkiye)

Location

Medipol Çamlıca Üniversity Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Neriman Güdücü, Ph.D.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Eight hospitals were matched into four pairs based on the number of midwives working in the delivery room and the annual number of births. Within each matched pair, one hospital was randomly assigned to the intervention group and the other to the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 26, 2026

Study Start

January 1, 2025

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Data are available from the corresponding author upon reasonable request

Locations