Effects of Baby Massage on Parenting Stress and Attachment in Premature

Sponsor
Chung Shan Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04255797
Collaborator
(none)
84
1
1
16
5.2

Study Details

Study Description

Brief Summary

This study is an experimental randomized controlled clinical trial. To explore the effect of infant massage on parental pressure and parent-child attachment of premature infants. The intervention time was from 5 days after birth to discharge from premature infants. Data were collected at five time points in longitudinal, before massage (T0), one week (T1), four weeks (T2), and eight weeks ( T3), 12 weeks (T4). Parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group visited premature babies as usual and contacted premature babies according to general nursing instructions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: baby massage
N/A

Detailed Description

The organ development of premature infants is not yet mature, leading to higher morbidity and mortality. Even with advanced technology, parents and families still need to put more effort into taking care of these premature babies so that they can survive. Empirical evidence indicates that baby massage can help parents reduce stress and establish parent-child relationships, but few studies have been applied to parents of premature babies during hospitalization. Based on this, the purpose of this study is: 1. To explore the effect of infant massage on reducing parental pressure; 2. To compare the gender differences of parental pressure; 3. To explore the effect of infant massage on parent-child attachment; 4. Compare the gender difference of parent-child attachment relationship between parents of premature infants. An experimental randomized controlled clinical trial study design was adopted to collect data at five points in time, namely before massage (T0), one week (T1), four weeks (T2), eight weeks (T3), and 12 weeks (T4 ). Using the parental stress scale and parent-child attachment scale. Parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group were routinely visiting premature babies. The effects of infant massage on parental pressure and parent-child attachment of premature babies at different time points were discussed, and the differences gender of parental pressure and parent-child attachment were compared. The results can increase the empirical research on baby massage, use the empirical knowledge to arouse the attention of nursing staff to baby massage, improve the quality of family-centered care, and pay attention to the needs of parents of different genders.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Clinical TrialRandomized Clinical Trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Chung Shan Medical University Hospital
Actual Study Start Date :
Mar 30, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

The experimental group will perform massage in an incubator. The researchers provide a natural plant-based massage oil for the parents.

Behavioral: baby massage
The steps are as follows:1. Monitor the physiological indicators before massage, 2. Assist premature babies to lie on prone, take off their clothes and diapers, and then apply the baby's massage oil to the hands of both parents to warm them. 3. In the incubator, slight pressure touch the baby's body with warm palms and fingers.

Outcome Measures

Primary Outcome Measures

  1. Parenting Stress [Up to 12 weeks]

    Parents Stress Index-Short Form is a tool for measuring parental stress in premature babies. There are 36 questions in total. Each question uses the Liker's five-point scoring, with a maximum of 180 points and a minimum of 36. The greater the pressure.

  2. Maternal Attachment [Up to 12 weeks]

    Maternal Attachment Inventory consists of 26 questions, each of which uses the Liker's four-point scoring method, with a maximum of 104 points and a minimum of 26 points. The higher the score, the better the relationship between mother and baby.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Single premature infants with a birth week of 30-37 weeks, weighing 1500-2500 grams;

  2. The pediatrician assesses the stability of vital signs;

  3. Premature infants without congenital abnormalities (such as congenital heart disease) or central nervous system dysfunction (such as intraventricular hemorrhage, epilepsy, etc.); Parents who meet the conditions for premature infants are the study subjects.

Exclusion Criteria:
  1. Parents performing kangaroo care;

  2. Parents younger than 20 years of age;

  3. Parents with mental illness or substance abuse;

  4. Single parent father or mother.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung Shan Medical University Hospital Taichung Taiwan 40201

Sponsors and Collaborators

  • Chung Shan Medical University

Investigators

  • Principal Investigator: Lien Jen Hwu, Chung Shan Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chung Shan Medical University Hospital, Assistant professor, Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT04255797
Other Study ID Numbers:
  • CS19135
First Posted:
Feb 5, 2020
Last Update Posted:
Jul 1, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2021