Clinical trial NCT04255797: Effects of Baby Massage on Parenting Stress and Attachment in Premature
Official title: Chung Shan Medical University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parenting Stress
timeFrame: Up to 12 weeks
measure: Maternal Attachment
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Lien Jen Hwu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.