Postpartum DepressionNCT06377176
Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament
A study testing Massage therapy in people with Postpartum Depression, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 50 years
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Jun 2021to 3 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Edinburgh Postnatal Depression Scale (EPDS) score more and equal to 13.
- Must be able to read.
- All types of delivery.
- Full-term gestation.
- Healthy infant.
Who cannot join
- Drug abuse history.
- Bipolar.
- Schizophrenia history.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Community Health Center
Sleman, Special Region of Yogyakarta, 55584
About this study
Official title: Massage Therapy for Infants and Mothers
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.
Read the detailed 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.
- Conditions
- Postpartum Depression
- Being tested
- Massage therapy
- Keywords
- Massage Therapy, Postpartum Depression, Stress, Fatigue, Infant Temperament
- Medical subject headings
- Depression, Postpartum, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
the intervention group underwent ten sessions of twice-weekly mother and infant massage therapy for five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Massage therapy for mother and infant. Receives: Other: Massage therapy |
| Control group | No intervention | the control group received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Score of mother depression on postpartum. EPDS score greater than or equal to 13.
Measured: 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.
Secondary outcomes (3)
Stress
The score of mother's stress. PSS-14 score range from 0-56. High scores indicate more stress.
Measured: 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.
Fatigue
The score of mothers fatigue. Fatigue scores range from 0-10. High Scores indicate more fatigue.
Measured: 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
The score of infant temperament. Infant temperament score 0-3. High scores indicate as a difficult temperament.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start16 Jun 2021
- Primary completion3 Oct 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evi Nurhidayati, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377176
- Sponsor's protocol ID
- NTUNHSEN
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage Therapy for Infants and Mothers
- ClinicalTrials.gov ID
- NCT06377176
- Acronym / sponsor ID
- NTUNHSEN
- Conditions
- Postpartum Depression
- Keywords
- Massage Therapy, Postpartum Depression, Stress, Fatigue, Infant Temperament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Massage therapyMassage therapy for mother and infant. |
| Control group | No intervention | –the control group received standard care. |
Who may qualify
- Ages
- 1 month to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Edinburgh Postnatal Depression Scale (EPDS) score more and equal to 13.
- Must be able to read.
- All types of delivery.
- Full-term gestation.
- Healthy infant.
Key exclusion criteria (3 listed)
- Drug abuse history.
- Bipolar.
- Schizophrenia history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapythe intervention group underwent ten sessions of twice-weekly mother and infant massage therapy for five weeks. | Other | Intervention group |
Primary outcome
Depression
Time frame: 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.
3 secondary outcomes
Stress
Time frame: 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.
Fatigue
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Postpartum Depression, run by National Taipei University of Nursing and Health Sciences at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.