The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants

The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial

This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.

Study Overview

• Status: Recruiting
• Conditions: Premature Infants; Sleep Quality; Vital Signs; NICU; İnfant Stress; İnfant Comfort
• Intervention / Treatment: Other: Infant Massage Therapy

Detailed Description

This randomized controlled study evaluates the impact of massage therapy on preterm infants' sleep quality, stress levels, comfort, and vital signs in the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants born between 35 and 37 weeks of gestation and meeting inclusion criteria will be randomly assigned to either an intervention group receiving massage or a control group receiving standard care.

The intervention consists of a 15-minute massage administered three times daily for three consecutive days by a trained researcher. Massage includes gentle stroking and circular movements of the legs, arms, back, and hands, following a standardized protocol. Physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation), sleep patterns (using actigraphy and chronometer), and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale will be recorded before and after the intervention.

Data will be analyzed using SPSS version 25. Group homogeneity will be assessed with chi-square or Fisher's exact tests, within-group comparisons with paired t-tests, and between-group comparisons with independent t-tests. Significance will be set at p < 0.05. This study aims to provide evidence on the efficacy of massage therapy as a non-pharmacological intervention to improve preterm infants' comfort, reduce stress, and enhance sleep quality in NICU settings.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RIDVAN AKDOĞAN, PhD; Phone Number: +905413980680; Email: ridvanakdogan@yyu.edu.tr
• Study Contact Backup: Name: YUSUF GÜRGAN, Msc Student; Phone Number: +905442941180; Email: yusufgurgan95@gmail.com

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Van, Turkey, Turkey (Türkiye), 65090
      • Recruiting
      • Van Regional Training and Research Hospital
      • Contact: RIDVAN AKDOĞAN, Assist. Prof. (PhD); Phone Number: 05413983680; Email: ridvanakdogan@yyu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preterm infants born between 35-37 weeks gestational age.
• Admitted to the neonatal intensive care unit (NICU).
• Medically stable and cleared for massage therapy by neonatologist.
• Parental/guardian consent obtained.

Exclusion Criteria:

• Infants with congenital anomalies or major medical complications.
• Infants requiring mechanical ventilation or intensive respiratory support.
• Infants with known neurological disorders.
• Parental/guardian refusal or inability to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care.	Other: Infant Massage Therapy; Preterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence.
No Intervention: Control - Standard Care; Preterm infants receiving standard care only, without massage intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality of Preterm Infants	Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.	Measured daily over 3 days of massage intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Comfort Level	Measured using Premature Infant Comfort Scale , higher scores indicate lower comfort.	Assessed before first massage and after last massage session (Day 3)
Infant Stress Levels	Measured using Neonatal Stress Scale; higher scores indicate greater stress.	Assessed before first massage and after last massage session (Day 3)
Heart Rate of Preterm Infants During Massage Therapy	Heart rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. Unit of measure: beats per minute (bpm).	Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Respiratory Rate of Preterm Infants During Massage Therapy	Respiratory rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. The outcome will be expressed as breaths per minute.	Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Oxygen Saturation of Preterm Infants During Massage Therapy	Oxygen saturation will be measured noninvasively using pulse oximetry to assess physiological response to massage therapy. The outcome will be expressed as percentage (%).	Baseline (prior to the first massage session) and immediately after each massage session over 3 days

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: comfort; stress reduction; NICU; sleep quality; Preterm infants; vital signs; neonatal massage
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Premature Birth; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: YUZUNCU_YIL_UNIVERSITY_NICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to researchers. Data will be accessible starting 6 months after publication of the primary results and will remain available for 5 years.
• IPD Sharing Time Frame: IPD and supporting documents will be available beginning six months after the publication of the primary study results and will remain accessible for a period of five years.
• IPD Sharing Access Criteria: Qualified researchers may request access to de-identified individual participant data, the study protocol, and statistical analysis plan. Requests must be submitted via email to the corresponding author, and data will be shared under a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No