Infant Abdominal Massage on Postnatal Stress Level

NCT05650424 | Completed

• 1 other identifier: HKUCTR-3008
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parenting; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difficult child

  week 4

• Parental distress & Parent-child dysfunctional interaction

  week 4

• Difference in parental stress with the presence of partner participation

  week 4

• Correlation between parental stress and self-reported compliance of the intervention

  week 4

Study Arms (2)

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)

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

Other: Abdominal massage training

Interventions

Abdominal massage training OTHER

please refer to group description

Intervention (Receive abdominal massage training); Wait-listed Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Parents with babies who had abdominal surgery.
• Currently participating in any other massage related studies.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39342220 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 14, 2022
• Study Start: October 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)