The Effect of the Training Program on Increasing Sleep Quality in Pregnancy to Maternal Sleep Quality

NCT ID: NCT04262349

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-30

Study Completion Date

2020-12-30

Brief Summary

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The aim of this study is to compare the control group and the intervention to be applied to the education program used to increase sleep quality in nulliparous women.

Detailed Description

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The study was a randomized controlled training intervention study in the pre-test and post-test order. The population of the study consisted of nulliparous pregnant women who applied to the Konya Dr. Ali Kemal Belviranlı Maternity and Children Hospital Pregnancy School and met the criteria for inclusion in the study at time of the study. Sample size was calculated with G \* Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization. During the conduct of the study, all pregnant women who applied to the pregnant school and met the criteria for participation in the study were recorded in the pre-training registry and numbered in the order of registration. Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

: The study was a randomized controlled training intervention study. Sample size was calculated with G \* Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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intervention

Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure".

Group Type EXPERIMENTAL

sleep education

Intervention Type BEHAVIORAL

As a training program to increase sleep, pregnant women will be given 2 training sessions per week for two weeks and four sessions in total for 60 minutes.

control

Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sleep education

As a training program to increase sleep, pregnant women will be given 2 training sessions per week for two weeks and four sessions in total for 60 minutes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* pregnant women
* between 28 and 32 gestational weeks

Exclusion Criteria

* under 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Habibe BAY

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neriman Soğukpınar

Role: STUDY_DIRECTOR

Ege University

Locations

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Ege University

Selçuk, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bay Ozcalik H, Sogukpinar N. The Effect of Sleep Enhancement Educational Program on Maternal Sleep Quality for Nulliparous Pregnant Women: A Randomized-Controlled Trial. Int J Behav Med. 2025 Feb;32(1):11-20. doi: 10.1007/s12529-024-10261-x. Epub 2024 Jan 29.

Reference Type DERIVED
PMID: 38286916 (View on PubMed)

Other Identifiers

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0000-0001-5786-4385

Identifier Type: -

Identifier Source: org_study_id

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