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

NCT07322731 | Recruiting

• 1 other identifier: YUZUNCU_YIL_UNIVERSITY_NICU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vital Signs; Premature Infants; Sleep Quality; İnfant Stress; İnfant Comfort; NICU

Keywords

Preterm infants; neonatal massage; NICU; sleep quality; stress reduction; comfort; vital signs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Infant Comfort Level

  Assessed before first massage and after last massage session (Day 3)

• Infant Stress Levels

  Assessed before first massage and after last massage session (Day 3)

• Heart Rate of Preterm Infants During Massage Therapy

  Baseline (prior to the first massage session) and immediately after each massage session over 3 days

• Respiratory Rate of Preterm Infants During Massage Therapy

  Baseline (prior to the first massage session) and immediately after each massage session over 3 days

• Oxygen Saturation of Preterm Infants During Massage Therapy

  Baseline (prior to the first massage session) and immediately after each massage session over 3 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care.

Other: Infant Massage Therapy

Control - Standard Care

NO INTERVENTION

Preterm infants receiving standard care only, without massage intervention.

Interventions

Infant Massage Therapy OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 35 Months - 37 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Regional Training and Research Hospital

Van, Turkey, 65090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

RIDVAN AKDOĞAN, PhD

CONTACT

+905413980680; ridvanakdogan@yyu.edu.tr

YUSUF GÜRGAN, Msc Student

CONTACT

+905442941180; yusufgurgan95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking; open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are randomly assigned to either the intervention group, which receives massage therapy, or the control group, which receives standard care. Randomization is performed using the Urn method. Each participant is assigned to only one group (parallel design). The intervention is applied three times daily for 15 minutes over three consecutive days.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 7, 2026
• Study Start: August 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)