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Completed

NCT Number: NCT07315971

The Effect Of Health Development Behavıour Traınıng In Pregnancyon Sleep Qualıty And Physıcal Actıvıty Levels

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Adnan Menderes Üniversitesi

Aydin, 09100, Turkey (Türkiye)

About this study

This study is a pre-test post-test randomized controlled experimental research. The population of the study consisted of 620 pregnant women, and the sample included a total of 57 pregnant women, with 27 in the experimental group and 30 in the control group. Prior to the intervention, individual interviews were conducted, and written consent was obtained from the participants. Subsequently, the questionnaire prepared by the researcher, the Pittsburgh Sleep Quality Index (PSQI), and the Pregnancy Physical Activity Questionnaire (PPAQ) were administered. The experimental group received health-promoting behavior education for six weeks, with sessions held once a week for 30 minutes at a Family Health Center, in a room designated by the center's staff during working hours. At the end of the training, the scales were administered again, and one month after the completion of the education, the PSQI and PPAQ were re-administered. The data obtained from the study were analyzed using the SPSS 25.0 package program at a 95% confidence interval and a significance level of 0.05. The normal distribution of the data was evaluated using the Kolmogorov-Smirnov test. Parametric tests were used when normal distribution assumptions were met, and non-parametric tests were applied when these assumptions were not satisfied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

HEALTH PROMOTION BEHAVIOR TRAINING

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effect Of Health Development Behavıour Traınıng In Pregnancy On Sleep Qualıty And Physıcal Actıvıty Levels: A Randomızed Controlled Experımental Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 5, 2026
Registry last updated
Jan 7, 2026

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