The Effect of Tub vs Sponge Bathing on the Comfort of Premature Infants

NCT03796312 | Completed

• 1 other identifier: 455111
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The integumentary system protects the underlying body from the external environment, such as shocks, temperature, ultraviolet radiation, chemicals, and other threats. There is a considerable body of clinical evidence highlighting the importance of the stratum corneum and its barrier functions, which are especially beneficial for newborns. Given the dramatic transition from the aqueous womb to the dry terrestrial environment at birth, studies describing adaptations made by the skin barrier within the first month of life assume greater importance. The skin of the baby is morphologically and functionally different from the skin of adults. Neonatal skin is thinner, more fragile, and drier than adult skin; it is difficult to maintain fluid-electrolyte balance and temperature regulation. Notwithstanding, structure and function of skin continues to improve during the first months and even years of life. Special care procedures are nonetheless necessary to ensure healthy development, to protect the skin from irritation and reddening, and to help the newborn feel well. Therefore, this study, taking the form of a randomized controlled trial, aims to examine the effectiveness of tub bathing and sponge bathing on the physiological parameters (heart rate, respiration rate, oxygen saturation, body temperature) and comfort of late preterm infants. Increasing comfort and physiological stabilization in premature infants during neonatal care improves their neurophysiological development. Bathing procedures that support this development and will not expose the newborn to stress should be preferred.

Conditions

Preterm Infant; Premature Birth

Keywords

Bathing; Comfort; Neonatal intensive care unit; Nursing care; Premature infant; Skin care

Outcome Measures

Primary Outcomes (1)

• Neonatal Comfort

  Data on comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing. The ComfortNeo scale was used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting. Comfort was inferred based on infant behavior 10 minutes before bathing and 10 minutes after bathing.

  An average of 1 year

Secondary Outcomes (4)

• Heart Rate

  An average of 1 year

• Oxygen Saturation

  An average of 1 year

• Respiration Rate

  An average of 1 year

• Body Temperature

  An average of 1 year

Study Arms (2)

Tub Bathing

EXPERIMENTAL

In this group, preterm infants were given tub bathing.

Behavioral: Tub Bathing

Sponge Bathing

ACTIVE COMPARATOR

Separate cotton cloths were prepared for each body area in the sponge bath. The room temperature was set to 26-27°C to prevent hypothermia. The temperature of the water used for sponge bathing was set to 37-38°C. Alongside the bath, the infant was placed on a flat, protected surface and washed from a bowl of water, using the same mild cleanser. The eyes, face, and head were wiped and dried while the baby was wrapped in a blanket. The wrap was opened so that body parts could be washed, dried, and then immediately rewrapped, after which infants were diapered.

Behavioral: Sponge Bathing

Interventions

Tub Bathing BEHAVIORAL

The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel.

Tub Bathing

Sponge Bathing BEHAVIORAL

Sponge bathing is routine care of the clinic

Sponge Bathing

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All inborn infants with a gestational age of 34 weeks and 0 days to 36 weeks and 6 days (late preterm) were eligible to participate in this study.

You may not qualify if:

• Participants were excluded from the study if they were connected to
• a mechanical ventilator,
• if they had bathed in the last 12 hours,
• if within the first 78 hours of the postoperative period,
• had a central catheter,
• had received either a sedative and/or muscle relaxant,

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Universty

Antalya, 07000, Turkey (Türkiye)

Location

Related Publications (3)

• Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.

  PMID: 15561658 BACKGROUND

• Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.

  PMID: 22375955 BACKGROUND

• Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.

  PMID: 31442786 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Emine EFE

  Akdeniz University Children's Health and the Nursing Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physiological data was collected by nurses trained by the lead researcher. Data on neonatal comfort behavior was collected by a second researcher and by research nurses who had been trained by the lead researcher. Those responsible for data collection were blinded as to the allocation of infants they were assessing.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: A randomized controlled two-group pre-test and repeated post-test study design were adopted. Preterm infants were randomly allocated before bathing by the researcher using a random computer-generated table to one of two groups: sponge bathing (routine care) or tub bathing. The bathing procedures were performed by the researcher. Nurses and a second researcher were blinded to the study hypotheses.

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 8, 2019
• Study Start: November 20, 2015
• Primary Completion: November 29, 2016
• Study Completion: November 29, 2016
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)