The Effects of Laughter Yoga and Progressive Muscle Relaxation Exercises on Pregnancy Symptoms and Pregnancy-Related Anxiety in Primiparous Women in the First Trimester (LY-PMR)
The Effects of Laughter Yoga and Progressive Muscle Relaxation Exercises on Pregnancy Symptoms and Pregnancy-Related Anxiety in Primiparous Women in the First Trimester: A Randomized Controlled Trial
Pregnancy involves substantial physical and emotional changes. During the first trimester, women may experience various pregnancy-related symptoms and anxiety as they adapt to pregnancy. These symptoms and concerns may affect their daily lives and overall well-being. Laughter yoga and progressive muscle relaxation are non-pharmacological approaches that may help women cope with these experiences.
This randomized controlled study aims to examine the effects of laughter yoga and progressive muscle relaxation exercises on pregnancy symptoms and pregnancy-related anxiety among primiparous women in the first trimester. Participants will be randomly assigned to one of three groups: laughter yoga, progressive muscle relaxation, or control. Women in the intervention groups will participate in structured online sessions of laughter yoga or progressive muscle relaxation exercises, while women in the control group will continue their routine care. Pregnancy symptoms and pregnancy-related anxiety will be assessed at baseline, Day 30, and Day 60. The study will compare changes in these outcomes across the three groups to determine the effects of the interventions.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
The first trimester of pregnancy (up to 13 weeks and 6 days of gestation) is characterized by significant physiological and psychological changes. Common pregnancy-related symptoms include nausea and vomiting, fatigue, sleep disturbances, breast tenderness, dizziness, and changes in appetite. In addition, concerns about fetal health, pregnancy progression, and the transition to motherhood may contribute to pregnancy-related anxiety. These concerns may be particularly relevant for primiparous women experiencing pregnancy for the first time.
Midwives play an important role in assessing pregnancy-related symptoms and psychological needs and supporting maternal well-being. Non-pharmacological interventions, such as laughter yoga and progressive muscle relaxation (PMR), may provide supportive approaches to managing physical discomfort and psychological difficulties during pregnancy.
Laughter yoga combines simulated laughter exercises with breathing techniques and relaxation activities. PMR is a structured relaxation technique involving the systematic tensing and relaxing of different muscle groups. Both approaches may promote relaxation and psychological well-being. However, evidence comparing their effects on pregnancy symptoms and pregnancy-related anxiety, particularly among primiparous women in the first trimester, remains limited.
This randomized controlled study aims to evaluate and compare the effects of laughter yoga and PMR on pregnancy symptoms and pregnancy-related anxiety in primiparous women during the first trimester.
Participants will be randomly assigned to one of three groups: laughter yoga, PMR, or control. Both intervention groups will receive online sessions via Zoom twice weekly for four weeks, with each session lasting approximately 30 minutes (eight sessions in total). The laughter yoga group will participate in structured laughter exercises, breathing techniques, and relaxation activities. The PMR group will perform systematic muscle tensing and relaxation exercises. The control group will continue to receive routine antenatal care without either study intervention during the intervention period.
Pregnancy symptoms and pregnancy-related anxiety will be assessed at baseline (Day 1), Day 30, and Day 60 using the designated study instruments. The findings are expected to contribute to the evidence on non-pharmacological approaches that may support woman-centered antenatal midwifery care.
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Havva TOKGÖZ KEKEÇ, phD Student
- Номер телефона: 05061550317
- Электронная почта: havvatokgoz9142@gmail.com
Места учебы
-
-
Çankırı
-
Çankırı, Çankırı, Турция (Туркие), 18100
- Рекрутинг
- Çankırı State Hospital
-
Контакт:
- Havva TOKGÖZ KEKEÇ, phD Student
- Номер телефона: 05061550317
- Электронная почта: havvatokgoz9142@gmail.com
-
Главный следователь:
- Havva Tokgöz KEKEÇ, phD student
-
-
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Being 18 years of age or older.
- Having a spontaneous pregnancy.
- Being in the first trimester of pregnancy (up to 13 weeks and 6 days of gestation).
- Being able to read, write, and communicate in Turkish.
- Voluntarily agreeing to participate in the study and providing written informed consent.
Exclusion Criteria:
- Having a diagnosis of high-risk pregnancy or serious obstetric complications that prevent participation in exercise (e.g., placenta previa, uncontrolled gestational hypertension or preeclampsia, threatened preterm labor requiring bed rest, or cervical insufficiency).
- Having a multiple pregnancy.
- Having a pregnancy conceived through assisted reproductive techniques (e.g., IVF) or a history of recurrent pregnancy loss (two or more miscarriages).
- Having a diagnosed psychiatric disorder (e.g., major depression, anxiety disorder, or psychosis).
- Having orthopedic, neurological, cardiovascular, or chronic respiratory diseases that prevent participation in light exercise or laughter yoga.
- Having a history of alcohol or substance use during pregnancy.
- Having a fetal anomaly or intrauterine growth restriction detected by ultrasonography.
- Having previously participated in laughter yoga sessions.
- Regularly participating in structured psychoeducation, psychological support programs, or complementary mind-body practices that may affect pregnancy symptoms, stress, anxiety, or relaxation levels during the study period (e.g., prenatal yoga, meditation, mindfulness, hypnobirthing, or progressive muscle relaxation exercises).
- Having a history of abdominal surgery associated with ongoing complications or physical limitations that may prevent safe participation in the interventions.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: Laughter Yoga Group
Participants assigned to this group will receive an online laughter yoga intervention over four weeks. The intervention will consist of eight sessions, conducted twice a week, with each session lasting approximately 30 minutes. The sessions will include simulated laughter exercises, breathing techniques, and relaxation activities. |
Laughter yoga is a structured intervention combining simulated laughter exercises, breathing techniques, rhythmic clapping, light warm-up movements, and playful activities. Participants will attend live online group sessions via Zoom, conducted by a researcher certified in laughter yoga. The first session will include brief information about laughter yoga, its principles, and breathing techniques. Each session will last approximately 30 minutes and will consist of deep breathing exercises (10 minutes), clapping and warm-up exercises (5 minutes), playful activities (5 minutes), and laughter exercises followed by relaxation (10 minutes). The intervention will be delivered twice weekly for four weeks, comprising eight sessions in total. Participants will be organized into groups of 5 to 25 individuals. Attendance will be monitored, and reminder messages will be sent via WhatsApp and/or SMS before sessions. |
|
Экспериментальный: Progressive Muscle Relaxation Group
Participants assigned to this group will receive an online progressive muscle relaxation intervention over four weeks. The intervention will consist of eight sessions, conducted twice a week, with each session lasting approximately 30 minutes. Participants will be guided through systematic tensing and relaxing of different muscle groups to promote physical and mental relaxation. |
Progressive muscle relaxation is a structured relaxation technique involving the sequential tensing and relaxing of different muscle groups to help participants recognize and reduce muscle tension. Participants will attend live online group sessions via Zoom, guided by the researcher. The first session will include brief information about the purpose, benefits, and application steps of the technique. Participants will also receive a written and illustrated educational brochure. During sessions, participants will be guided through exercises involving the hand, arm, shoulder, face, neck, back, abdominal, hip, leg, and foot muscle groups. Each muscle group will be tensed for approximately 5-7 seconds and then relaxed for 10-15 seconds, accompanied by slow and controlled breathing. Each session will last approximately 30 minutes. The intervention will be delivered twice weekly for four weeks, comprising eight sessions in total. Participants will be organized into groups of 5 to 25 individu |
|
Без вмешательства: Control Group
Participants assigned to the control group will continue to receive routine antenatal care throughout the study period. They will not receive laughter yoga or progressive muscle relaxation interventions during the intervention period. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pregnancy Symptoms Inventory (PSI)
Временное ограничение: Day 1 (baseline), Day 30, and Day 60.
|
The Pregnancy Symptoms Inventory (PSI), developed by Foxcroft et al. (2013) and adapted into Turkish by Gürkan and Güloğlu (2018), consists of 42 items and two sections. Section 1 assesses symptom frequency using a 4-point Likert scale (0-3), with total scores ranging from 0 to 126. Higher scores indicate more frequent pregnancy symptoms. Section 2 assesses the limitation of daily activities using a 3-point Likert scale (1-3), with total scores ranging from 42 to 126. Higher scores indicate greater activity limitation. Higher scores in both sections represent worse outcomes. The Cronbach's alpha coefficient of the Turkish version was 0.82. Internal consistency will also be assessed in the present study. |
Day 1 (baseline), Day 30, and Day 60.
|
|
Pregnancy-Related Anxiety Questionnaire (PRAQ)
Временное ограничение: Day 1 (baseline), Day 30, and Day 60.
|
The Pregnancy-Related Anxiety Questionnaire (PRAQ), developed by Brunton et al. (2018) and adapted into Turkish by Solt Kırca and Kanza Gül (2020), consists of 33 items rated on a 4-point Likert scale. It includes nine subdimensions, and 11 items are reverse-scored. Total scores range from 33 to 132. There is no established cut-off point. Higher scores indicate greater pregnancy-related anxiety and represent a worse outcome. The Cronbach's alpha coefficient of the Turkish version was 0.85. Internal consistency will also be assessed in the present study. |
Day 1 (baseline), Day 30, and Day 60.
|
Соавторы и исследователи
Спонсор
Спонсор
Следователи
Следователи
- Директор по исследованиям: Hacer Alan Dikmen, phD, Selcuk University
Публикации и полезные ссылки
Общие публикации
- Agapinar Sahin S, Bekar M. The influence of laughter yoga on pregnancy symptoms, mental well-being, and prenatal attachment: A randomized controlled study. Health Care Women Int. 2023 Jun;44(6):782-801. doi: 10.1080/07399332.2022.2164284. Epub 2023 Jan 10.
- Aydinlik O, Akin B. The effect of superstitions during pregnancy on quality of life and pregnancy adjustment. J Eval Clin Pract. 2025 Apr;31(3):e14162. doi: 10.1111/jep.14162. Epub 2024 Oct 13.
- Shariatpanahi M, Faramarzi M, Barat S, Farghadani A, Shirafkan H. Prevalence and risk factors of prenatal anxiety disorders: A cross-sectional study. Health Sci Rep. 2023 Aug 21;6(8):e1491. doi: 10.1002/hsr2.1491. eCollection 2023 Aug.
- Alves AC, Cecatti JG, Souza RT. Resilience and Stress during Pregnancy: A Comprehensive Multidimensional Approach in Maternal and Perinatal Health. ScientificWorldJournal. 2021 Aug 13;2021:9512854. doi: 10.1155/2021/9512854. eCollection 2021.
- Gürkan ÖC, Güloğlu ZE, 2019. Gebelik semptom envanteri'nin Türkçe geçerlilik güvenilirlik çalışması. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi.
- Şolt, A. & Kanza Gül, D. (2020). Pregnancy-related Anxiety Scale (The PrAS): Validity and Reliability Study of its Turkish Version. Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 7(4), 529-537. DOI: 10.34087/cbusbed.757864
- Nasiri S, Akbari H, Tagharrobi L, Tabatabaee AS. The effect of progressive muscle relaxation and guided imagery on stress, anxiety, and depression of pregnant women referred to health centers. J Educ Health Promot. 2018 Mar 1;7:41. doi: 10.4103/jehp.jehp_158_16. eCollection 2018.
- Liu CY, Liu TH, Huang CW, Lai CC, Lin CH, Su KP. Effects of laughter therapy on depression and anxiety: A dose-response meta-analysis with trial sequential analysis. J Psychiatr Res. 2026 Aug;199:50-61. doi: 10.1016/j.jpsychires.2026.04.006. Epub 2026 Apr 16.
- Kiyak S, Kocoglu-Tanyer D. Effectiveness of progressive muscle relaxation and laughter therapy on mental health and treatment outcomes in women undergoing in vitro fertilization: A randomized controlled trial. Res Nurs Health. 2021 Dec;44(6):945-956. doi: 10.1002/nur.22187. Epub 2021 Oct 3.
- Foxcroft KF, Callaway LK, Byrne NM, Webster J. Development and validation of a pregnancy symptoms inventory. BMC Pregnancy Childbirth. 2013 Jan 16;13:3. doi: 10.1186/1471-2393-13-3.
- Dollin, L. A., Solomon, R. J., & Research (2018). Effectiveness of progressive muscle relaxation on stress among Women with Infertility. International Journal of Nursing Education, 6(4), 363-366. https://doi.org/10.5958/2454-2660.2018.00088.1
- Akbas P, Yaman Sozbir S. The effect of progressive muscle relaxation exercise on the intensity of symptoms and quality of sleep and quality of life in pregnant women with restless leg syndrome. Patient Educ Couns. 2023 Aug;113:107768. doi: 10.1016/j.pec.2023.107768. Epub 2023 Apr 28.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 2026/587
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data will not be shared with other researchers. The data will be used solely for the purposes of this study and reported in aggregate form to protect participants' privacy and confidentiality.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .