ParentingNCT05650424
Infant Abdominal Massage on Postnatal Stress Level
A study testing Abdominal massage training in people with Parenting and Stress, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this randomized control trial is to find out the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year old. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Abdominal massage training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to 1 Dec 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parents aged 18 or above.
- Parents with 0-1 year old full term babies without medical treatment of colic.
- Able to communicate or read Chinese and have not tried applying infant massage on their babies.
Who cannot join
- Parents with babies who had abdominal surgery.
- Currently participating in any other massage related studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Infant Abdominal Massage on Postnatal Stress Level Among Chinese Parents in Hong Kong
The goal of this randomized control trial is to find out the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year old. The main question[s] it aims to answer are:
- examine the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong
- the relationship between the compliance of the intervention and the change of parental stress level Participants in intervention group will receive a abdominal massage training session and will perform on their baby. Parental stress level will be assess week 0 and four weeks .
If there is a comparison group: Researchers will compare wait-listed control group to see if there is any change on their parental stress level
Read the detailed description
same as above
- Being tested
- Abdominal massage training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massage trainingOther
please refer to group description
| Study group | Role | What they receive |
|---|---|---|
| Wait-listed Control | Active comparator | wait-listed control group will be put on wait list and receive abdominal massage class training on week 4 (posttest) Receives: Other: Abdominal massage training |
| Intervention (Receive abdominal massage training) | Experimental | Intervention group will receive abdominal massage training class and they will perform abdominal massage on their baby for 4 week. Parental stress level will be assessed on week 0 and week 4 Receives: Other: Abdominal massage training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress level
is parenting stress which was assessed by the parental stress scale of the Chinese version of the Parenting Stress Index (PSI-SF) (4th version) with 3 subscales: Difficult child (DC), Parental distress (PD) and Parent-child dysfunctional interaction (P-CDI)
Total Score: 36-180 ( Higher score implies higher parental stress level)
Measured: week 4
Secondary outcomes (4)
Difficult child
Difficult child (DC) which is one of the subscales of PSI-SF
Subscale score: 12-60 (Higher score mean a worse outcome)
Measured: week 4
Parental distress & Parent-child dysfunctional interaction
Parental distress (PD) and Parent-child dysfunctional interaction (P-CDI) which are the other two subscales of PSI-SF
Each Subscale score: 12-60 (Higher score mean a worse outcome)
Measured: week 4
Difference in parental stress with the presence of partner participation
Difference in total parental stress level (PSI-SF) with the presence of partner participation to join the massage training class
Measured: week 4
Correlation between parental stress and self-reported compliance of the intervention
Correlation between parental stress and self-reported compliance of the intervention
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Oct 2021
- Primary completion31 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai Sze Ki, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650424
- Sponsor's protocol ID
- HKUCTR-3008
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai VSK, Fong DYT. The effects of infant abdominal massage on the parental stress level among Chinese parents in Hong Kong - A mixed clustered RCT. BMC Complement Med Ther. 2024 Sep 28;24(1):342. doi: 10.1186/s12906-024-04636-6.
PubMed 39342220
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Infant Abdominal Massage on Postnatal Stress Level Among Chinese Parents in Hong Kong
- ClinicalTrials.gov ID
- NCT05650424
- Acronym / sponsor ID
- HKUCTR-3008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Dec 2022 (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.
The goal of this randomized control trial is to find out the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year old. The main question[s] it aims to answer are:
- examine the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong
- the relationship between the compliance of the intervention and the change of parental stress level Participants in intervention group will receive a abdominal massage training session and will perform on their baby. Parental stress level will be assess week 0 and four weeks .
If there is a comparison group: Researchers will compare wait-listed control group to see if there is any change on their parental stress level
Detailed description
same as above
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-listed Control | Active comparator | Other: Abdominal massage trainingwait-listed control group will be put on wait list and receive abdominal massage class training on week 4 (posttest) |
| Intervention (Receive abdominal massage training) | Experimental | Other: Abdominal massage trainingIntervention group will receive abdominal massage training class and they will perform abdominal massage on their baby for 4 week. Parental stress level will be assessed on week 0 and week 4 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Parents aged 18 or above.
- Parents with 0-1 year old full term babies without medical treatment of colic.
- Able to communicate or read Chinese and have not tried applying infant massage on their babies.
Key exclusion criteria (2 listed)
- Parents with babies who had abdominal surgery.
- Currently participating in any other massage related studies.
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 |
|---|---|---|
| Abdominal massage trainingplease refer to group description | Other | Intervention (Receive abdominal massage training), Wait-listed Control |
Primary outcome
Parental stress level
Time frame: week 4
is parenting stress which was assessed by the parental stress scale of the Chinese version of the Parenting Stress Index (PSI-SF) (4th version) with 3 subscales: Difficult child (DC), Parental distress (PD) and Parent-child dysfunctional interaction (P-CDI) Total Score: 36-180 ( Higher score implies higher parental stress level)
4 secondary outcomes
Difficult child
Time frame: week 4
Parental distress & Parent-child dysfunctional interaction
Time frame: week 4
Difference in parental stress with the presence of partner participation
Time frame: week 4
Correlation between parental stress and self-reported compliance of the intervention
Time frame: week 4
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 14 Dec 2022.
- Derived from this study: PubMed 39342220Lai VSK, Fong DYT. The effects of infant abdominal massage on the parental stress level among Chinese parents in Hong Kong - A mixed clustered RCT. BMC Complement Med Ther. 2024 Sep 28;24(1):342. doi: 10.1186/s12906-024-04636-6.
- 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 Abdominal massage training in people with Parenting and Stress, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 2 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 14 Dec 2022. 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 Hong Kong. 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?
Parental stress level (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05650424, which also lists 1 linked publication.
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 14 Dec 2022.