- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07794371
Effects of Laughter Yoga in the Third Trimester
Laughter Yoga for Pregnant Women in the Third Trimester: Evaluation of Its Effects on Stress, Psychosocial Health, and Brain Fog
Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. While some women perceive pregnancy as a source of joy and happiness because of the anticipated arrival of a new family member, others may perceive it as a source of worry, anxious anticipation, and stress.
In addition to physical and hormonal changes, expectant mothers experience numerous psychological and social changes during pregnancy. A woman's psychological state and experiences may influence the course of pregnancy, while pregnancy itself may also cause significant changes in her psychological state. Women who are unable to adequately adapt to these changes may experience various psychological problems due to pregnancy-related bodily changes and physical complaints, concerns about parenthood, changes in family and social roles, fear of childbirth, unwanted pregnancy and miscarriage, new challenges and needs arising from pregnancy, concerns and worries about the baby, parenting stress, low self-esteem, a persistent tendency toward negative thinking, lack of social support and social isolation, marital and partner-related problems, domestic violence, adverse life experiences, alcohol and tobacco use during pregnancy, chronic diseases, inadequate weight gain during pregnancy, exposure to sexual abuse, employment-related issues, and financial concerns. If these psychological problems arising during pregnancy are not resolved, emotional distress may continue to increase, potentially leading to stress and depression
Symptoms of brain fog, such as forgetfulness and absent-mindedness, may occur once or twice during pregnancy or may persist throughout pregnancy. Brain fog may become more pronounced during periods of fatigue or irregular sleep, such as in the early or late stages of pregnancy. Studies conducted among pregnant women have shown that fluctuations in progesterone and estrogen during pregnancy may lead to impairments in attention, memory, and executive functioning because the brain is sensitive to changes in hormone levels.
Laughter yoga (Laughter Therapy/Laughter Yoga), developed by Dr. Kataria, is a therapeutic method that combines yogic breathing techniques with laughter exercises. A systematic review reported that laughter yoga physiologically increases oxygenation, relaxes muscles, stimulates circulation and the immune system, increases endorphin release and thereby enhances the pain threshold and pain tolerance, strengthens mental functioning by reducing stress hormone levels, decreases depression and anxiety, improves sleep quality, and promotes psychological well-being by enhancing interpersonal relationships and social interaction. The literature highlights the positive physiological, psychological, and social effects of laughter on health. Although laughter yoga has increasingly been used in healthcare in recent years, positive outcomes have been reported across different age groups and health conditions. Laughter yoga performed with pregnant women has been reported to reduce the frequency of pregnancy-related symptoms and increase psychological well-being and prenatal attachment levels. However, no studies examining its effects on the outcomes addressed in the present study were identified in the literature. Therefore, this study aims to determine the effects of laughter yoga on perceived stress, psychosocial health, and brain fog among pregnant women in the third trimester.
Keywords: laughter, pregnancy, stress, psychosocial health, brain fog
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ağri
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Ağrı, Ağri, Turecko (Türkiye), 04100
- Ağrı İbrahim Çeçen University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being 18 years of age or older
- Having no communication barriers
- Applying for antenatal education during the study period
- Volunteering to participate in the study
- Being in the third trimester of pregnancy
- Having no condition that would prevent participation in laughter yoga sessions
Exclusion Criteria:
- Refusing to participate in the study
- Providing incomplete responses or failing to answer the questions in the questionnaire
- Having a high-risk pregnancy
- Having a multiple pregnancy (e.g., twins)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 1.laughter
laughter therapy
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Participants will receive a total of **4-5 laughter therapy sessions** during the study period.
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Žádný zásah: 2 CONTROL
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Descriptive Information Form:
Časové okno: Baseline and immediately after completion of the final laughter yoga session
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This form was developed by the researchers based on the relevant literature to assess the sociodemographic characteristics of the participants.
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Baseline and immediately after completion of the final laughter yoga session
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Perceived Stress Scale (PSS):
Časové okno: Baseline and immediately after completion of the final laughter yoga session
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The scale, developed by Cohen et al., consists of 14 items and was designed to assess the extent to which situations in an individual's life are perceived as stressful.
Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very Often (4)."
Seven positively worded items are reverse-scored.
In the Turkish adaptation, reliability, and validity study of the Perceived Stress Scale conducted by Eskin et al., the Turkish PSS-14 demonstrated an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87.
The scale was concluded to be a valid and reliable instrument for assessing perceived stress.
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Baseline and immediately after completion of the final laughter yoga session
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The Antenatal Psychosocial Health Assessment Scale
Časové okno: Baseline and immediately after completion of the final laughter yoga session
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This scale was developed by Yıldız to assess psychosocial health during pregnancy.
It consists of 46 items and six subscales: characteristics related to pregnancy and the spousal relationship, characteristics related to anxiety and stress, characteristics related to domestic violence, characteristics related to the need for psychosocial support, familial characteristics, and characteristics related to physical and psychosocial changes associated with pregnancy.
The total score is divided by the number of items to obtain a mean score ranging from 1 to 5. Scores closer to 1 indicate greater psychosocial health problems during pregnancy, with a score of 1 representing very poor psychosocial health.
The Cronbach's alpha coefficient of the scale was reported as 0.93.
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Baseline and immediately after completion of the final laughter yoga session
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Brain Fog Scale
Časové okno: Baseline and immediately after completion of the final laughter yoga session
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The scale consists of 30 items and three subscales.
The total score ranges from 30 to 150.
The Cognitive Symptoms subscale is scored between 17 and 85, the Physical Symptoms subscale between 8 and 40, and the Psychological Symptoms subscale between 5 and 25.
Higher scores on the subscales and/or the overall scale indicate higher levels of brain fog.
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Baseline and immediately after completion of the final laughter yoga session
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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