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临床试验/NCT06377176
NCT06377176已完成不适用

Massage Therapy for Infants and Mothers

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Depression

研究概览

简要总结

Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament.

详细描述

Data collection procedures Preparation stage Two research assistants with a master's degree in midwifery and two years of clinical experience were chosen by the researcher. The researcher describes and discusses the purpose, intervention protocol, research instrument, and COVID-19 protocol of the study. All research assistants as data collectors and the therapist are required to have received either two doses of the COVID-19 vaccine or a handwash or hand sanitizer, in addition to wearing a face mask. Furthermore, the research assistant requested to accompany the researcher as they conducted the informed consent and questionnaire administration process with the participant on an estimated three separate occasions. The research assistant conducted an informed consent test on the participants after three observations; individuals who adequately showcased their ability were granted employment as research assistants. Daily activity logs must be included on self-report forms completed by the research assistant.

Additionally, the researcher designates the mother and infant massage therapist; for the baby massage, the researcher collaborates with a physiotherapist and midwives who possess more than two years of clinical experience and a midwife who holds certification in baby massage therapy. Following this, the massage therapist and researcher demonstrated and discussed the massage technique with the mother and child. During the intervention, the researcher additionally provided the mothers with a baby doll so that they could serve as models for baby massage to the mothers while the physiotherapists or midwives attended to the infants. Upon the conclusion of the intervention, the mothers would be capable of performing massage independently.

Implementation stage The researcher employed the EPDS questionnaire as a screening tool to identify postpartum mothers for depression; participants were chosen based on their EPDS score of 13. Following this, the investigator proceeds to deliver an elucidation of the study's aims and methodology to the participant. On the day of the questionnaire's initiation, the consent form is duly signed by the respondent. The research assistant confirmed the questionnaire's completion upon its return and requested that the respondents complete it, including the respondent code, and place it in the file holder.

Following the completion of the initial questionnaires by both groups during the meeting, the intervention group underwent ten sessions of twice-weekly mother and infant massage therapy over the course of five weeks. The mother promptly resubmits the questionnaires following the conclusion of the newborn massage therapy. A month later, the mother proceeds to complete the remaining questionnaires.

A regimen for the respondent and therapist to receive massages was formulated by the researcher. The receiver dictates the duration of the massage. The researcher then created a massage regimen to be executed twice weekly for five weeks. Respondents 1 through 30 adhered to a Monday through Thursday routine, but those 31 through 52 observed Tuesday through Friday. Four to six participants were massaged per therapist, and a total of seven therapists were hired. The massage hours of operation are from 7:00 am to 5:00 pm. A two-hour period separated each responder; for instance, in the scenario where one respondent received a massage at 7:00 am, the subsequent respondent would receive one at 9:00 am.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Edinburgh Postnatal Depression Scale (EPDS) score more and equal to
  • •Must be able to read.
  • •All types of delivery.
  • •Full-term gestation.
  • •Healthy infant.

排除标准

  • •Drug abuse history.
  • •Schizophrenia history.

研究组 & 干预措施

Intervention group

Experimental

Massage therapy for mother and infant.

干预措施: Massage therapy (Other)

Control group

No Intervention

the control group received standard care.

结局指标

主要结局

Depression

时间窗: Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.

Score of mother depression on postpartum. EPDS score greater than or equal to 13.

次要结局

  • Fatigue(Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.)
  • Stress(Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.)
  • Infant temperament(Pretest: At the initial encounter, eligible as a respondent and agreed to participate in the research then fill out the questionnaires.. Posttest 1: after the end of massage therapy session (5 weeks). Posttest 2: 1 month after posttest 1.)

研究者

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

Evi Nurhidayati

Principal Investigator

National Taipei University of Nursing and Health Sciences

研究点 (1)

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