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Completed

NCT Number: NCT06499259

The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU

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).

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mandala coloring

Other

Mandala Pack and Application: The mandala pack is a pack consisting of 7 different patterns suitable for adults and 12 pencils. Mandala patterns will be photocopied by the researcher. Packages will be given to the mothers about mandala coloring and their questions will be answered. The choice of the color of the paint to be used in mandala coloring will be entirely up to the mother. No guidance will be given in this regard.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Before the first mandala painting session (pre-test)

    Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.

  2. Visual Analog Scale (VAS)

    Time frame: After the 7th mandala painting session (7 days after the first session) (post-test)

    Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.

Secondary outcomes

  1. State Trait Anxiety Inventory (STAI)

    Time frame: Before the first mandala painting session (pre-test)

    The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96.

  2. State Trait Anxiety Inventory (STAI)

    Time frame: After the 7th mandala painting session (7 days after the first session) (post-test)

    The STAI (STAI-State Trait Anxiety Inventory) Scale consist of 20 items each and State Anxiety Scale was used in this study. The State Anxiety Scale has a rating scale consisting of (1) not at all, (2) a little, (3) a lot, (4) completely, according to the degree to which the person feels the current situation. Ten items (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) are reverse scored. The cronbach's alpha coefficient of the scale was 0.94 0.96.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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