- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315971
The Effect Of Health Development Behavıour Traınıng In Pregnancyon Sleep Qualıty And Physıcal Actıvıty Levels
The Effect Of Health Development Behavıour Traınıng In Pregnancy On Sleep Qualıty And Physıcal Actıvıty Levels: A Randomızed Controlled Experımental Study
The aim of this study is to determine the effect of health-promoting behavior education on the sleep quality and physical activity levels of pregnant women. 1.2. The research hypotheses are as follows:
H0 hypotheses:
- Ho (1): Education on healthy lifestyle behaviors during pregnancy does not affect sleep quality in pregnant women.
- Ho (2): Education on healthy lifestyle behaviors during pregnancy does not affect physical activity levels in pregnant women.
H1 hypotheses:
- H1 (1): Education on healthy lifestyle behaviors during pregnancy improves sleep quality in pregnant women.
- H1 (2): Education on healthy lifestyle behaviors during pregnancy increases physical activity levels in pregnant women.
The study group received health promotion training for six weeks. Data were collected by administering the scales three times: before, immediately after, and one month later. The control group received no training and only underwent routine pregnancy examinations and follow-up at the family health center. The scales were administered at the same times as the pregnant women in the study group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aydin, Turkey (Türkiye), 09100
- Aydın Adnan Menderes Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pregnant women who were: • in the early third trimester,
- had at least a primary school education,
- had no communication barriers were included.
Exclusion Criteria:
Incomplete completion of the data collection tools used in the study,
- Having a psychiatric diagnosis (major depression, psychotic disorders, intellectual disability),
- Being pregnant under the age of 18,
- Having a chronic disease (such as diabetes, heart disease, hypertension, cancer),
- Multiple pregnancy were considered exclusion criteria.
- Not following the training programs included in the study (at least two trainings),
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group continued to receive the routine care
|
|
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Experimental: experimental group
The study group received training on health promotion during pregnancy in addition to usual care provided by health professionals.
|
Exercise During Pregnancy When Should Exercise Be Started During Pregnancy?
Which Exercises Are Recommended/Not Recommended During Pregnancy?
How Intense Should Exercise Be During Pregnancy?
How Long Should Exercise Last?
Points to Consider When Exercising Exercise Examples Health Responsibility Pregnancy Monitoring Smoking During Pregnancy, Alcohol, and Substance Use During Pregnancy Sexuality During Pregnancy Hygiene and General Care During Pregnancy Sleep During Pregnancy Sleep Problems During Pregnancy Recommendations for Quality Sleep During Pregnancy Interpersonal Relationships Effective Communication Skills Stress Management Factors That Can Cause Stress During Pregnancy Positive Methods for Coping with Stress During Pregnancy The intervention group received 6 weeks of face-to-face training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Questionnaire for Pregnant Women
Time Frame: 28th week of pregnancy
|
Physical Activity Questionnaire for Pregnant WomenThe Turkish validity and reliability of the scale, developed by Chasan Taber et al. in 2004, was determined by Çırak et al.
It consists of 36 questions that determine the level of physical activity and exercise in pregnant women.
This scale evaluates 32 activities performed by pregnant women: housework and care activities (n=13), occupational activities (n=5), sports and exercise activities (n=8), transportation (n=3), and sedentary lifestyle (n=3).
The intensity of physical activity is expressed in METs (metabolic equivalents).
In open-ended questions, the MET value of the activity is determined by referring to the Review.
Activity intensities are grouped as sedentary (0.6 MET).
Activity types are classified as housework/care activities, occupational activities, and sports/exercise.
In this study, the Cronbach's alpha coefficient of the scale was found to be 0.65.
|
28th week of pregnancy
|
|
The Pittsburgh Sleep Quality Index
Time Frame: 28th week of pregnancy
|
PSQI developed by Buysse et al. has been shown to have sufficient internal consistency (Cronbach's alpha = 0.80), test-retest reliability, and validity (Buysse et al.
It was adapted into Turkish by Ağargün et al.
The PSQI is a 19-item self-report scale that assesses sleep quality and disturbance over the past month.
It consists of 24 questions: 19 self-report questions and 5 questions to be answered by a spouse or roommate.
The 18 scored questions comprise 7 components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleep Medication Use, and Daytime Dysfunction.
Each component is scored on a scale of 0-3.
The total score of the 7 components gives the total scale score.
The total score ranges from 0-21.
A total score greater than 5 indicates "poor sleep quality".
Permission was obtained for the scale's use.
Cronbach's alpha coefficient of the scale was found to be 0.71.
|
28th week of pregnancy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Questionnaire for Pregnant Women
Time Frame: 33th week of pregnancy
|
The Turkish validity and reliability of the scale, developed by Chasan Taber et al. in 2004, was determined by Çırak et al.
It consists of 36 questions that determine the level of physical activity and exercise in pregnant women.
This scale evaluates 32 activities performed by pregnant women: housework and care activities (n=13), occupational activities (n=5), sports and exercise activities (n=8), transportation (n=3), and sedentary lifestyle (n=3).
The intensity of physical activity is expressed in METs (metabolic equivalents).
In open-ended questions, the MET value of the activity is determined by referring to the Review.
Activity intensities are grouped as sedentary (0.6 MET).
Activity types are classified as housework/care activities, occupational activities, and sports/exercise.
In this study, the Cronbach's alpha coefficient of the scale was found to be 0.65.
|
33th week of pregnancy
|
|
The Pittsburgh Sleep Quality Index
Time Frame: 33th week of pregnancy
|
PSQI developed by Buysse et al. has been shown to have sufficient internal consistency (Cronbach's alpha = 0.80), test-retest reliability, and validity.
It was adapted into Turkish by Ağargün et al.
The PSQI is a 19-item self-report scale that assesses sleep quality and disturbance over the past month.
It consists of 24 questions: 19 self-report questions and 5 questions to be answered by a spouse or roommate.
The 18 scored questions comprise 7 components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleep Medication Use, and Daytime Dysfunction.
Each component is scored on a scale of 0-3.
The total score of the 7 components gives the total scale score.
The total score ranges from 0-21.
A total score greater than 5 indicates "poor sleep quality".
Permission was obtained for the scale's use.
Cronbach's alpha coefficient of the scale was found to be 0.71.
|
33th week of pregnancy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Questionnaire for Pregnant Women
Time Frame: 38th gestational weeks
|
The Turkish validity and reliability of the scale, developed by Chasan Taber et al. in 2004, was determined by Çırak et al.
It consists of 36 questions that determine the level of physical activity and exercise in pregnant women.
This scale evaluates 32 activities performed by pregnant women: housework and care activities (n=13), occupational activities (n=5), sports and exercise activities (n=8), transportation (n=3), and sedentary lifestyle (n=3).
The intensity of physical activity is expressed in METs (metabolic equivalents).
In open-ended questions, the MET value of the activity is determined by referring to the Review.
Activity intensities are grouped as sedentary (0.6 MET).
Activity types are classified as housework/care activities, occupational activities, and sports/exercise.
In this study, the Cronbach's alpha coefficient of the scale was found to be 0.65.
|
38th gestational weeks
|
|
The Pittsburgh Sleep Quality Index
Time Frame: 38th gestational weeks
|
PSQI developed by Buysse et al. has been shown to have sufficient internal consistency (Cronbach's alpha = 0.80), test-retest reliability, and validity.
It was adapted into Turkish by Ağargün et al.
The PSQI is a 19-item self-report scale that assesses sleep quality and disturbance over the past month.
It consists of 24 questions: 19 self-report questions and 5 questions to be answered by a spouse or roommate.
The 18 scored questions comprise 7 components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleep Medication Use, and Daytime Dysfunction.
Each component is scored on a scale of 0-3.
The total score of the 7 components gives the total scale score.
The total score ranges from 0-21.
A total score greater than 5 indicates "poor sleep quality".
Permission was obtained for the scale's use.
Cronbach's alpha coefficient of the scale was found to be 0.71.
|
38th gestational weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Safiye Özvurmaz, Phd, Aydın Adnan Menderes University, Faculy of Nursing, Division Public Health Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-21347915-050.04.04-264603l
- Randomızed Controlled Experıme (Registry Identifier: Randomızed Controlled Experıme)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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