Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07322731

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Premature Infants Dyssomnias Female Urogenital Diseases and Pregnancy Complications Mental Disorders NICU Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Urogenital Diseases Vital Signs İnfant Comfort İnfant Stress

Age range

35 month–37 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Regional Training and Research Hospital

Van, Turkey, 65090, Turkey (Türkiye)

Location status: Recruiting

Location contact

RIDVAN AKDOĞAN, Assist. Prof. (PhD)

CONTACT

[email protected]

05413983680

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sleep Quality of Preterm Infants

    Time frame: Measured daily over 3 days of massage intervention

    Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.

Secondary outcomes

  1. Infant Comfort Level

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

    Measured using Premature Infant Comfort Scale , higher scores indicate lower comfort.

  2. Infant Stress Levels

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

    Measured using Neonatal Stress Scale; higher scores indicate greater stress.

  3. Heart Rate of Preterm Infants During Massage Therapy

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

    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).

  4. Respiratory Rate of Preterm Infants During Massage Therapy

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

    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.

  5. Oxygen Saturation of Preterm Infants During Massage Therapy

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

    Oxygen saturation will be measured noninvasively using pulse oximetry to assess physiological response to massage therapy. The outcome will be expressed as percentage (%).

Study contacts

Contact information is provided by the study sponsor or research team.

RIDVAN AKDOĞAN, PhD

CONTACT

[email protected]

+905413980680

YUSUF GÜRGAN, Msc Student

CONTACT

[email protected]

+905442941180

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.