Clinical trial NCT06499259: The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers with Babies in NICU
Official title: The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers with Babies in the Neonatal Intensive Care Unit: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Parents
Psychological Stress
Keywords: Anxiety
Stress
Neonatal Intensive Care Unit
Mandala coloring
Mothers
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 72
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group (routine care) and experimental group (mandala painting)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).

Detailed description: The health status of the baby and the duration of stay in the intensive care unit cause the mother to experience varying levels of stress and anxiety. It is very important to determine the levels of stress and anxiety in mothers of newborns hospitalized in the Neonatal Intensive Care Unit and to take interventions to reduce it. This study will be conducted to evaluate the effect of mandala coloring activity on stress and anxiety levels in mothers whose babies are hospitalized in the neonatal intensive care unit. It is thought to make an important contribution to the field because it will be a randomized controlled study on the effect of mandala painting activity on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.

Type of study: The study was planned as a randomized controlled experimental study.

In the G\*Power program, it was determined that it would be sufficient to include 30 participants in the study groups with a 5% alpha margin of error, 0.95 confidence interval, 0.95 effect size and 0.95 power. Considering the randomization list and possible losses, the sample size was increased by 20% and it was decided to include 72 mothers in the study, each group consisting of 36 participants.

Data Collection: Before starting the study, the purpose of the study will be explained to the participant by the researcher and informed consent will be obtained. Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. The mothers in the control group will not receive any treatment within the scope of the study. When they are included in the study, data collection forms will be applied as the first measurement; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. After the completion of the data collection forms, the mothers in the control group will be given a mandala package consisting of 7 applications.

H0: Mandala coloring activity has no effect on stress and anxiety in mothers whose infants are hospitalized in the neonatal intensive care unit.

H1: Mandala coloring activity has a positive effect on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.

Eligibility criteria: Inclusion Criteria:

* Mothers whose baby has been in the neonatal intensive care unit for at least 3 days and staying in the mother's hotel,
* Having agreed to participate in the research/approved the informed consent form
* No visual or hearing impairment
* Being over 18 years old,
* Being at least literate
* The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement)
* Must not have a diagnosis of mental illness/anxiety disorder

Exclusion Criteria:

* Mothers with communication and perception problems will not be included in the study.
* Mothers with comprehension and speech problems will not be included in the study.
* Mothers with psychiatric illness and taking medication will not be included in the study.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Before the first mandala painting session (pre-test)
measure: Visual Analog Scale (VAS)
timeFrame: After the 7th mandala painting session (7 days after the first session) (post-test)
Secondary outcomes:
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Before the first mandala painting session (pre-test)
measure: State Trait Anxiety Inventory (STAI)
timeFrame: After the 7th mandala painting session (7 days after the first session) (post-test)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Özdemir, PhD
role: STUDY_DIRECTOR
References:
citation: Sari Ozturk C, Demir K. The Effect of Mandala Activity and Technology-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Mother-Infant Attachment of Primiparous Women: A Randomized Controlled Study. J Med Syst. 2023 Apr 1;47(1):44. doi: 10.1007/s10916-023-01942-3.
citation: Robinson EM, Baker R, Hossain MM. Randomized Trial Evaluating the Effectiveness of Coloring on Decreasing Anxiety Among Parents in a Pediatric Surgical Waiting Area. J Pediatr Nurs. 2018 Jul-Aug;41:80-83. doi: 10.1016/j.pedn.2018.02.001. Epub 2018 Feb 10.
citation: Ozsavran M, Ayyildiz TK. The effect of mandala art therapy on the comfort and resilience levels of mothers who have children with special needs: A randomized controlled study. Child Care Health Dev. 2023 Nov;49(6):1032-1045. doi: 10.1111/cch.13110. Epub 2023 Mar 16.