Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377176
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2024-03-04
Brief Title:
Postpartum Massage Therapy for Women and Infants The Effect on Maternal Depression Stress Fatigue and Infant Temperament
Sponsor:
National Taipei University of Nursing and Health Sciences
Organization:
National Taipei University of Nursing and Health Sciences
Study Overview
Official Title:
Massage Therapy for Infants and Mothers
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studys hypothesis was an improvement in maternal depression stress fatigue and infant temperament
Detailed Description:
Data collection procedures Preparation stage Two research assistants with a masters 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 studys aims and methodology to the participant On the day of the questionnaires initiation the consent form is duly signed by the respondent The research assistant confirmed the questionnaires 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 700 am to 500 pm A two-hour period separated each responder for instance in the scenario where one respondent received a massage at 700 am the subsequent respondent would receive one at 900 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 infants 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 025 at a significance level of 005 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
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 studys aims and methodology to the participant On the day of the questionnaires initiation the consent form is duly signed by the respondent The research assistant confirmed the questionnaires 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 700 am to 500 pm A two-hour period separated each responder for instance in the scenario where one respondent received a massage at 700 am the subsequent respondent would receive one at 900 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 infants 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 025 at a significance level of 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None