Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06377176 |
| Other study ID # |
NTUNHSEN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2021 |
| Est. completion date |
October 3, 2021 |
Study information
| Verified date |
April 2024 |
| Source |
National Taipei University of Nursing and Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
The control group is administered standard care or routine mother and infant care. As part of
usual care, the CHC midwife conducts routine assessments of the infant's height and weight,
in addition to furnishing the mother with relevant information. Furthermore, after completing
the second posttest, mother and infant massage therapy is implemented for the control group.
Sample size This research uses G-power calculation to examine the number of samples needed.
Based on the G-power calculation and the assumption of a minimum medium effect size of 0.25%
at a significance level of 0.05 and 80% power, an estimated sample size of 86 participants is
necessary. Considering a 20 percent attrition rate, 104 individuals were recruited in total.
By utilizing convenience sampling, this research incorporates all eligible participants. Two
participants were ineligible to participate in this research due to a family-related concern.
Data analysis The data was analyzed by univariate, bivariate, and multivariate. Bivariate
statistics using independent t-tests, Chi-square, Fisher exact test, Pearson correlation; and
for the multivariate data using generalized estimated equation.
