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

Pregnancy Related Clinical Trial

Official title:

The Effect of the Training Program on Sleep Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262349
• Other study ID #: 0000-0001-5786-4385
• Status: Completed
• Phase: N/A
• Start date: December 30, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2022
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnant women

• between 28 and 32 gestational weeks

Exclusion Criteria:

• under 18 years old

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Ege University	Selçuk	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Pittshburg Sleep Quality Index (PUKI): PUKI is a self-report scale that evaluates sleep quality and disorders in the past month.; It consists of 24 questions in total, 19 of which are self-report based questions.; The last 5 questions are not included in the scoring, they are used for clinical evaluation.; Each item of the scale is evaluated as 0-3 points.; Seven "component" scores are created from nineteen items. While some components consist of evaluating a single substance, some components are the result of combining several items.; Components that make up the scale; subjective sleep quality, sleep delay, sleep duration, habitual sleep effectiveness, sleep disorders, use of sleeping pills and daytime dysfunction.; The scale total score is obtained by calculating the points of these seven components and the maximum scale score that can be obtained is 21.; Increased score indicates poor sleep quality.; A total scale score of 5 and above is expressed as bad sleep.	change in sleep quality in the 4th week of education