Clinical trial NCT06589648: The Effect of Mandala Coloring on Anxiety and Mental Fatigue in Pregnant Women Diagnosed With Threatened Preterm Labor
Official title: The Effect of Mandala Coloring on Anxiety and Mental Fatigue Levels in Pregnant Women Diagnosed With Threatened Preterm Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety During Pregnancy
Mental Fatigue
Mandala
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: mandala coloring
Primary purpose: OTHER

Brief summary: The research will be conducted in a pre-test-post-test control group randomized control design. The aim is to examine the effect of mandala work on anxiety and mental fatigue in pregnant women diagnosed with threatened preterm labor. Hypotheses

1. Mandala coloring work reduces the level of anxiety related to pregnancy in pregnant women diagnosed with threatened preterm labor.
2. Mandala coloring work reduces the level of anxiety in pregnant women diagnosed with threatened preterm labor.
3. Mandala coloring work reduces the level of mental fatigue in pregnant women diagnosed with threatened preterm labor.

Pregnant women who meet the inclusion criteria will be given general information about the research before randomization, their consent will be obtained and pre-test data will be collected. Pregnant women whose pre-test data are collected will be assigned to the intervention and control groups using the simple randomization method.

Intervention group: Participants in the intervention group will be given a set of colored markers and a mandala coloring page and will be asked to color them at any time of the day and in any way they want during their hospitalization. Participants will be asked to take a picture of the mandala they colored and send it to the researcher after they are finished. Participants will be reminded daily so that they do not forget to do the activity. Research data will be collected a total of four times before randomization, on the 1st day, 2nd day and 3rd day after the mandala application was started.

Control Group: No intervention other than routine care will be made to the control group of the study, and research data will be collected at simultaneous time intervals with the experimental group.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who can read and write Turkish,
* Diagnosed with threatened preterm labor,
* Are between 32-36 weeks of gestation,
* Primiparous,
* Hospitalized,
* Open to communication (able to understand and answer questions) will be included in the sample.

Exclusion Criteria:

* Pregnant women with a history of miscarriage or stillbirth,
* Those who voluntarily withdrew from the study,
* Those with a history of psychiatric illness (self-report),
* Those who do not have a physical disability that would prevent them from coloring mandalas will be excluded from the study.

Primary outcomes:
measure: Pregnancy-Related Anxiety Scale
timeFrame: 0-3 day
Secondary outcomes:
measure: State Anxiety Inventory
timeFrame: 0-3 day
Other outcomes:
measure: Mental Fatigue Scale
timeFrame: 0-3 day
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University Medical Faculty Hospital
state: Konya/ Selçuklu
Study officials:
affiliation: KTO Karatay Univeristy
name: Karakoç
role: STUDY_DIRECTOR
References: