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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 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

171

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Çankırı
      • Çankırı, Çankırı, Turquie (Türkiye), 18100
        • Recrutement
        • Çankırı State Hospital
        • Contact:
        • Chercheur principal:
          • Havva Tokgöz KEKEÇ, phD student

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Expérimental: 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

Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pregnancy Symptoms Inventory (PSI)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Directeur d'études: Hacer Alan Dikmen, phD, Selcuk University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2026

Achèvement primaire (Estimé)

30 avril 2027

Achèvement de l'étude (Estimé)

30 avril 2027

Dates d'inscription aux études

Première soumission

1 novembre 2026

Première soumission répondant aux critères de contrôle qualité

9 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2026/587

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .