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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 novembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

171

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Çankırı
      • Çankırı, Çankırı, Turquia (Türkiye), 18100
        • Recrutamento
        • Çankırı State Hospital
        • Contato:
        • Investigador principal:
          • Havva Tokgöz KEKEÇ, phD student

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pregnancy Symptoms Inventory (PSI)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Hacer Alan Dikmen, phD, Selcuk University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de novembro de 2026

Conclusão Primária (Estimado)

30 de abril de 2027

Conclusão do estudo (Estimado)

30 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de novembro de 2026

Primeira postagem (Real)

10 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2026/587

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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