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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05650424
Other study ID # HKUCTR-3008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Description:

same as above


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 1, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Parents aged 18 or above. 2. Parents with 0-1 year old full term babies without medical treatment of colic. 3. Able to communicate or read Chinese and have not tried applying infant massage on their babies. Exclusion Criteria: 1. Parents with babies who had abdominal surgery. 2. Currently participating in any other massage related studies.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal massage training
please refer to group description

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
week 4
Secondary Difficult child Difficult child (DC) which is one of the subscales of PSI-SF
Subscale score: 12-60 (Higher score mean a worse outcome)
week 4
Secondary 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)
week 4
Secondary 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 week 4
Secondary Correlation between parental stress and self-reported compliance of the intervention Correlation between parental stress and self-reported compliance of the intervention week 4
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