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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)

9 de noviembre de 2026 actualizado por: Havva Tokgöz Kekeç, Selcuk University

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

171

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Çankırı
      • Çankırı, Çankırı, Turquía (Türkiye), 18100
        • Reclutamiento
        • Çankırı State Hospital
        • Contacto:
        • Investigador principal:
          • Havva Tokgöz KEKEÇ, phD student

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Experimental: 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

Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pregnancy Symptoms Inventory (PSI)
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Hacer Alan Dikmen, phD, Selcuk University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2026

Finalización primaria (Estimado)

30 de abril de 2027

Finalización del estudio (Estimado)

30 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Publicado por primera vez (Actual)

10 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2026/587

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .