The Effect of Safe Swaddling After Bathing on Stress and Comfort in Newborns

NCT06171997 | Completed

• 1 other identifier: Funda1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be conducted experimentally in the form of randomized controlled studies to determine the effect of safe swaddling of newborns after bathing on stress and comfort. The population of the research consists of newborns receiving treatment and care in the Neonatal Intensive Care Unit of a State Hospital located in the north of Turkey, and the sample consists of 72 babies who meet the sample selection criteria. Descriptive Characteristics Form, Newborn Stress Scale and Newborn Comfort Behavior Scale were used to collect data. Babies will be bathed in the bathtub and then swaddled. The baby will be placed in the incubator and kept for 15 minutes. After 15 minutes, the swaddle will be opened quietly and slowly, without disturbing the body posture. Stress and comfort scores will be given by two observers by video recording the babies before bathing, before swaddling and after swaddling.

Conditions

Stress; Comfort

Keywords

Newborn; Bath; Swaddling; Stress; Comfort

Outcome Measures

Primary Outcomes (2)

• change in stress

  The Newborn Stress scale will be used to evaluate stress in babies. The scale consists of 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and a total of 24 items in a 3-point Likert type. In scoring, each subgroup is evaluated between 0-2 points. The minimum score obtained from the scale is 0 points and the maximum is 16 points. An increase in the score indicates that the baby's stress level has increased. A change in stress is expected through safe swaddling after bathing compared to before bathing.

  15th minute after the procedure

• change in comfort

  Newborn Comfort Behavior Scale (COMFORTneo) will be used to evaluate comfort in babies. It has been stated that the lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort. A change in comfort is expected after bathing compared to before bathing through safe swaddling.

  15th minute after the procedure

Study Arms (2)

Swaddling after bath group

EXPERIMENTAL

Newborns in this group will be swaddled safely after bath.

Other: Swaddling after bath group

No swaddling after bath group

NO INTERVENTION

No action will be taken after bath.

Interventions

Swaddling after bath group OTHER

The babies were bathed in the bathtub. Then swaddling was done. The baby was taken into the incubator and waited for 15 minutes. At the end of 15 minutes, the swaddle was opened quietly and slowly, without disturbing the body posture. Stress and comfort scores were given by two observers by video recording the babies before bathing, before swaddling and after swaddling. Newborns' stress will be assessed with the Newborn Stress Scale and their comfort with the Newborn Comfort Behavior Scale.

Swaddling after bath group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The week of gestation is between 37 and 41 weeks,
• Birth weight being 2500 g and above,
• Having spontaneous breathing,
• Its physiological parameters are stable,
• Having completed the first 24 hours of life,
• No invasive interventions should be made before the bathing process.

You may not qualify if:

• Preterms with a gestational age of 22-37 weeks,
• Connected to mechanical ventilator,
• Those who have been wiped or bathed in the last 12 hours,
• Within the first 78 hours of the post-operative period,
• With central catheter,
• Diagnosed with sepsis,
• Those who use sedative and/or muscle relaxants,
• Those with congenital, chromosomal anomalies,

Sponsors & Collaborators

• Funda Kardas Ozdemir: lead

Study Sites (1)

Kafkas University

Kars, Kars, 36100, Turkey (Türkiye)

Location

Study Officials

• Kübra Sevgi, RN

  Kafkas University

  PRINCIPAL INVESTIGATOR

• Funda Kardaş Özdemir, PhD

  Kafkas University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 36 baby in experimental group and 36 baby in control group, a total of 72 bany will be included in the study.

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 15, 2023
• Study Start: February 15, 2022
• Primary Completion: December 15, 2023
• Study Completion: February 15, 2024
• Last Updated: January 28, 2026

Record last verified: 2023-12

Locations

TU (1)