Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU
Sponsor:
Istanbul Medeniyet University
Organization:
Istanbul Medeniyet University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GPower program it was determined that it would be sufficient to include 30 participants in the study groups with a 5 alpha margin of error 095 confidence interval 095 effect size and 095 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 participants 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
Type of study The study was planned as a randomized controlled experimental study
In the GPower program it was determined that it would be sufficient to include 30 participants in the study groups with a 5 alpha margin of error 095 confidence interval 095 effect size and 095 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None