NCT04255797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

January 30, 2020

Last Update Submit

June 29, 2021

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (2)

  • Parenting Stress

    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.

    Up to 12 weeks

  • Maternal Attachment

    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.

    Up to 12 weeks

Study Arms (1)

experimental group

EXPERIMENTAL

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

Behavioral: baby massage

Interventions

baby massageBEHAVIORAL

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.

experimental group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single premature infants with a birth week of 30-37 weeks, weighing 1500-2500 grams;
  • The pediatrician assesses the stability of vital signs;
  • 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.

You may not qualify if:

  • Parents performing kangaroo care;
  • Parents younger than 20 years of age;
  • Parents with mental illness or substance abuse;
  • Single parent father or mother.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

Related Publications (1)

  • Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14.

    PMID: 28235686RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Lien Jen Hwu

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

March 30, 2020

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

uncertain

Locations

TW(1)