The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss

NCT07060768 | Not Yet Recruiting

• 1 other identifier: EBYalova
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss. The main questions are: Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience? Researchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms. Participants will: Answer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.

Conditions

Perinatal Loss

Keywords

perinatal loss; resilience; perinatal grief

Outcome Measures

Primary Outcomes (2)

• Perinatal Grief

  Perinatal Grief will be assessed via Perinatal Grief Scale. The scale is a 5-point Likert-type scale and responses range from "strongly agree to strongly disagree". The scale includes three sub-dimensions: "active grief", "difficulty coping" and "hopelessness". The total number of items in the scale is 32. Items 11 and 32 of the scale have a positive sentence structure. These items are answered in reverse. While the total grief score that can be obtained from the scale varies between 32-160, the scores that can be obtained for each sub-dimension seperately. As the total perinatal grief score and the total score obtained from the sub-dimensions increase, it is determined that the individual's grief level is higher.

  1st day to 10th day

• Perinatal Grief Intensity

  Will be assessed via Perinatal Grief Intensity Scale. The scale consists of 14 items, rated on a 4-point Likert-type scale from strongly agree to strongly disagree, and three sub-dimensions: "reality", "confrontation with others", and "adaptation". The scale contains both positive and negative expressions. Therefore, items 1, 2, 3, and 6 are evaluated as reverse items in the scoring of the scale. When calculating the scores of the sub-dimensions, the score obtained from each item is added up and divided by the number of items in the sub-dimension. Thus, a total score between 1 and 4 is obtained from each sub-dimension. The following formula is used for the total score: 3.08 + (0.41 x reality sub-dimension mean score) - (0.2 x confrontation sub-dimension mean score) - (0.15 x harmony sub-dimension mean score) The score that can be obtained from the scale varies between 2.09 - 4.37. It is predicted that the intensity of grief that will be experienced increases as the score increases

  1st day to 10th day

Secondary Outcomes (1)

• Resilience

  1st day and 10th day

Study Arms (2)

Intervention

EXPERIMENTAL

This arm will have mandala coloring intervention

Other: Mandala Coloring

Control

NO INTERVENTION

This arm will not receive any intervention

Interventions

Mandala Coloring OTHER

Mandala coloring at least 20 minutes each day. Totally 10 days intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender people identify with the gender that aligns with the sex they were assigned at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experienced perinatal loss (neonatal death, fetal death, abortion) within the last six weeks

You may not qualify if:

• Serious psychological problem that requires intervention with the recommendation of a psychiatrist, such as having a previous mental disorder or use of antidepressants.
• Practicing alternative methods such as yoga, meditation, acupuncture

Sponsors & Collaborators

• University of Yalova: lead

Related Publications (3)

• Hutti MH, dePacheco M, Smith M. A study of miscarriage: development and validation of the Perinatal Grief Intensity Scale. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):547-55. doi: 10.1111/j.1552-6909.1998.tb02621.x.

  PMID: 9773366 BACKGROUND

• Kones MO, Kaydırak MM, Aslan E, Yildiz H. The Perinatal Grief Scale (33-item short version): validity and reliability of the Turkish version. Anadolu Psikiyatri Derg. 2017; 18(3): 231-236. doi:10.5455/apd.234509.

  BACKGROUND

• Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.

  PMID: 3407734 BACKGROUND

Central Study Contacts

Elif Balkan, PhD Student

CONTACT

+905423513125; elif.balkan@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 11, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share