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Status unknownNCT04255797Updated Jul 1, 2021

Effects of Baby Massage on Parenting Stress and Attachment in Premature

An interventional study of baby massage in Premature Birth, sponsored by Chung Shan Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Premature Birth

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03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 84 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • 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

Interventions

  • Behavioralbaby 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 weeks

  2. 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.

    Time frame: Up to 12 weeks

07

Study locations

1 site
  • Chung Shan Medical University Hospital
    Taichung, 40201, Taiwan
08

References and documents

Publications

  • 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. PubMed 28235686 ↗

Individual participant data

Plan to share: No — uncertain

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04255797
Lead sponsor
Chung Shan Medical University
Responsible party
Chung Shan Medical University Hospital (Assistant professor, Chung Shan Medical University) — Principal investigator
First posted
Feb 5, 2020
Start date
Mar 30, 2020
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Jul 1, 2021

Study contacts

Lien Jen Hwu
principal investigator · Chung Shan Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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