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Набор по приглашению NCT06851286

Effects of Laughter Therapy on Postpartum Mothers' Stress, Sleep, and Breastfeeding

Без фазы С лечением Postnatal Care Lactation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Laughter Therapy.
Кому может быть актуально
Состояния в реестре: Postnatal Care, Lactation. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Laughter Therapy Given to Mothers in The Postpartum Period on Their Perceived Stress, Sleep Quality and Breastfeeding Self-Efficacy Level; Randomized Controlled Trial

Обзор

Postnatal period is an important developmental transition period for women. Stress in the postnatal period is one of the most common mental health problems and most mothers report experiencing stress in the perinatal period. In addition, stress and negative mental health also threaten breastfeeding self-efficacy. The postnatal period is an important stage in terms of early initiation and maintenance of breastfeeding. Breastfeeding self-efficacy is a mother's perceived confidence in her ability to breastfeed her newborn baby. Therefore, midwives are expected to assess women and identify women in need of supportive interventions and consciously contribute to their treatment. Another common problem in the postnatal period is poor sleep quality. It was determined that an increase in sleep quality and perceived social support positively affected breastfeeding self-efficacy of postpartum women. In addition, poor sleep quality poses a threat for negative mental health outcomes for women in the postpartum period. Previous studies reflect mothers' desire for non-pharmacological interventions and a high degree of satisfaction with these therapies. Laughter therapy, one of the main non-pharmacological interventions, is recognised as a universal approach to reduce stress and anxiety. The postnatal period is a fragile period with physical and psychological changes as well as hormonal changes in the mother. Poor mental health of the mother poses a danger to the well-being of the mother and the baby. Mothers in the postpartum period need low-cost, easily accessible preventive interventions to prevent these problems. In this context, the aim of this study is to determine the effect of laughter therapy given to mothers in the postpartum period on perceived stress, sleep quality and breastfeeding self-efficacy level in mothers.

Подробное описание

The postnatal period is an important developmental transition period for women and mothers experience various difficulties. Therefore, midwives are expected to assess women and identify women in need of supportive interventions and consciously contribute to their treatment. Previous studies reflect mothers' desire for non-pharmacological therapies and a high degree of satisfaction with these therapies. Laughter therapy, one of the main non-pharmacological interventions, is recognised as a universal approach to reduce stress and anxiety. Laughter therapy is a new, simple, cost-effective, non-invasive, non-invasive, widely available online, easily accessible and effective method. Laughter therapy has been applied to many different patient populations and healthy individuals in a variety of settings, and studies have reported benefits such as improved sleep quality, decreased depression, pain and stress hormones, improved mood and life satisfaction, increased prenatal attachment and breastfeeding self-efficacy. These benefits document the positive role of laughter therapy in improving the quality of life of individuals. Laughter therapy is a type of cognitive-behavioural therapy that can improve physical, psychological and ultimately quality of life. Laughter therapy can be used for both preventive and therapeutic purposes. In contrast, the negative effects of laughter and humour are negligible.

In conclusion, laughter is a human and universal value. Using laughter effectively to improve well-being and facilitate adaptation to the changes experienced in this period can significantly improve quality of life. Mothers in the postpartum period need low-cost, easily accessible preventive interventions to prevent these problems. However, to achieve this, health professionals need to be aware of the most appropriate evidence-based interventions. The number of studies investigating the effect of laughter therapy on women's health is limited in Turkey. In order to increase evidence-based data, there is a need to investigate the potential effectiveness of laughter therapy interventions in terms of women's health. In this context, the aim of this study was to determine the effect of laughter therapy given to mothers in the postnatal period on perceived stress, sleep quality and breastfeeding self-efficacy level. It is thought that the results of this study will guide midwives to be aware of the effectiveness of laughter therapy and to plan interventions to improve the quality of life of mothers.

Вмешательства

  • Поведенческое Laughter Therapy
    A laughter yoga session; It is approximately 30 minutes and consists of four parts. These sections; hand clapping and warm-up exercises, deep breathing exercises, childish games and laughter exercises. In each laughter yoga session, the first three parts are the same, but the laughter exercises in the fourth part vary. In the first session of each new group, the introduction of laughter yoga, its purpose and objectives will be discussed. 10 minutes will be allocated for this section in the first

Первичные конечные точки

  • Perceived Stress Scale [Срок оценки: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60]
Вторичные конечные точки (1)
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60]

Критерии участия

Критерии включения

  • At least primary school graduate
  • Over the age of 18
  • Those who volunteer to participate in the research
  • Heterosexual
  • Having a single and healthy baby
  • Postpartum 1-12 month old baby
  • Women who can use Zoom program

Критерии исключения

  • Those who do not speak Turkish,
  • Those with hearing and visual impairments,
  • Those with mental disabilities,
  • Those diagnosed with a known psychiatric disease,
  • Mothers who do not breastfeed
  • Mothers who have babies with disabilities and chronic health problems
  • Women with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, vertiligo, severe heart disease, hemorrhoids, any type of hernia such as neck, waist or inguinal hernia, severe back pain, urinary incontinence, epilepsy, etc.),
  • Women who use medication or use another non-pharmacological method to reduce stress.

Women who develop an acute health problem in themselves or their babies, who have a sudden hospitalisation of the mother or baby, mothers who lose their babies, women who do not attend all of the laughter therapy sessions and women who cannot be reached after the application will be excluded from the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Selçuk University Faculty of Medicine Hospital — Konya

Публикации

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
  • Akın, B., Tanyer, D. (2021). SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması. HUHEMFAD, 8(1):117-2.
  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20. PMID 28630973
  • Zhao J, Yin H, Zhang G, Li G, Shang B, Wang C, Chen L. A meta-analysis of randomized controlled trials of laughter and humour interventions on depression, anxiety and sleep quality in adults. J Adv Nurs. 2019 Nov;75(11):2435-2448. doi: 10.1111/jan.14000. Epub 2019 May 9. PMID 30882915
  • Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243. PMID 27439375
  • Werner-Bierwisch T, Pinkert C, Niessen K, Metzing S, Hellmers C. Mothers' and fathers' sense of security in the context of pregnancy, childbirth and the postnatal period: an integrative literature review. BMC Pregnancy Childbirth. 2018 Dec 4;18(1):473. doi: 10.1186/s12884-018-2096-3. PMID 30509217
  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7. PMID 26869575
  • van der Wal CN, Kok RN. Laughter-inducing therapies: Systematic review and meta-analysis. Soc Sci Med. 2019 Jul;232:473-488. doi: 10.1016/j.socscimed.2019.02.018. Epub 2019 Mar 5. PMID 31029483

Идентификаторы

NCT: NCT06851286 · 2024/616 · Researcher

Первоисточники (государственные реестры)

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