Infant Abdominal Massage on Postnatal Stress Level

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

Study Overview

• Status: Completed
• Conditions: Stress; Parenting
• Intervention / Treatment: Other: Abdominal massage training

Detailed Description

same as above

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wait-listed Control; wait-listed control group will be put on wait list and receive abdominal massage class training on week 4 (posttest)	Other: Abdominal massage training; please refer to group description
Experimental: Intervention (Receive abdominal massage training); 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	Other: Abdominal massage training; please refer to group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Correlation between parental stress and self-reported compliance of the intervention	Correlation between parental stress and self-reported compliance of the intervention	week 4

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HKUCTR-3008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No