跳至主要内容
临床试验/NCT06851286
NCT06851286Enrolling By Invitation不适用

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

Selcuk University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
120
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

In the study, the process of assigning mothers to the laughter therapy and control groups was done by simple randomisation to ensure similarity between the groups. To ensure randomisation in the study, a table of random numbers was created by dividing into two groups according to the number determined on https://www.randomizer.org/. Two random number series (set 1 and set 2) between 1- 120 were created in the system using the Random Integer Generator method in the Numbers subheading of this site. The 120 women who met the inclusion criteria were assigned to 60 laughter therapy groups and 60 control groups in a 1:1 ratio by simple randomisation method. Which group was the intervention or control group was determined by drawing lots at the beginning of the study. The mothers included in the study did not know which group they were in at first. After the individuals who met the inclusion criteria and volunteered to participate in the study were determined, the participants were assigned

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

laughter therapy group

Experimental

After randomization is achieved, a WhatsApp group will be established with the mothers in the laughter therapy group. Before starting the application, the "Zoom" program will be downloaded to the phones or computers of the mothers in the laughter therapy group. Afterwards, an online application will be carried out in groups via Zoom, by determining a common day and time according to the working hours of the mothers and the researcher. Groups will be formed with at least 5-10 people, and laughter therapy will be applied to the groups for 4 weeks, 2 sessions per week, for a total of 8 sessions.

干预措施: Laughter Therapy (Behavioral)

control group

No Intervention

No intervention will be made to the control group, they will be asked to fill out the survey forms simultaneously.

结局指标

主要结局

Perceived Stress Scale

时间窗: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60

It was developed by Cohen, Kamarck \& Mermelste (1983), and in the reliability study, the Cronbach Alpha value was found to be 0.86. The Cronbach Alpha value of the "Perceived Stress Scale", which was adapted into Turkish by Bilge, Öğce, Genç and Oran (2007) and whose validity and reliability studies were conducted, was found to be 0.81. Three items of the scale, prepared in a 5-point Likert type (0 never, 4 very often), are reverse-worded (items 4, 5, 6), and five items are literal (items 1, 2, 3, 7, and 8). A total score of 0-32 is taken from the scale. It has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, and 6). The scale is evaluated on both total score and subscale scores. A high total score means a high perceived stress level. High scores from the subscales are a negative situation.

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Havva Tokgöz Kekeç

PhD Student, Msc Midwife

Selcuk University

研究点 (1)

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