The Effect of Massage on Preterm Babies

NCT06799572 | Not Yet Recruiting

• 1 other identifier: OBOZBUGA-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was planned as a randomized controlled experimental study with pre-test post-test design in order to examine the effect of massage on pain, comfort and nutritional status in infants undergoing NCPAP in the NICU, considering that massage may be effective in reducing the effectiveness of treatment and complications that may develop due to NCPAP by reducing stress in newborns undergoing NCPAP.In this research, answers to the following questions will be sought; Massage has an effect on pain in preterm infants receiving NCPAP therapy; H1: has an effect on pain. H2: has an effect on comfort. H3: has an effect on feeding intolerance (vomiting, abdominal distension, stool output...)

Conditions

PreTerm Neonate; nCPAP; Massage

Keywords

ncpap; massage; preterm

Outcome Measures

Primary Outcomes (3)

• Neonatal Infant Pain Scale (NIPS)

  Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et al. (1993). It was adapted into Turkish by Akdovan (1999). It is a pain assessment scale developed for premature and newborns and behaviourally evaluates the response to pain in invasive procedures. The total score in NIPS varies between 0 and 7, and scores higher than 3 indicate the presence of pain. (Akdovan, 1999). Six behavioural categories are assessed, with a minimum score of 0 and a maximum score of 7. High validity and reliability (r= .84-.92)

  5 day

• Daily Monıtoring Form

  This form is a daily monitoring form in which the baby's daily weight gain, feeding pattern, vomiting and abdominal distension, and the number of stools will be recorded

  5 day

• Neonatal Comfort Behaviour Scale (NCCS)

  The Turkish validity and reliability study of the Neonatal Comfort Behaviour Scale (NCCS) was conducted by Kahraman et al. in 2014. The NBBS is a Likert-type scale consisting of 6 parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. In newborns receiving mechanical ventilator support, the item "Respiratory Response" is evaluated and in those not receiving mechanical ventilator support, the item "Crying" is evaluated. In the validity and reliability study of the scale, Cronbach's alpha coefficient was found to be 0.85 for the primary researcher and 0.82 for the assistant researcher before care and 0.92 for the primary researcher and 0.85 for the assistant researcher after care. \[18\]. The score that can be obtained from the scale is between 6-30. If the total score of the scale is between 9-13, the baby is comfortable; if it is between 14-30, it shows that the baby has pain or distress, the baby is uncomfortab

  5 day

Study Arms (2)

massage group

EXPERIMENTAL

* A follow-up form and scales will be applied to the babies before the first massage session. * Massage will be applied by the researcher in the incubator for 15 minutes * Massage will be done twice a day, morning and evening * Babies will be massaged for a total of 5 days (10 sessions) * In the massage to be applied to babies, liquid petroleum jelly will be used to provide lubrication on the skin. Vaseline is recommended for newborn skin care because it is the most effective, reliable and inexpensive. \[19, 20\]. * After 10 sessions of massage, Pain and Comfort scales will be applied and the final evaluation of the follow-up form will be made. * Each massage will be performed 1 hour after feeding. * Data such as vomiting, distension, defecation frequency, etc. of the baby the day before will be recorded on the Newborn Monitoring Form before the morning massage to be performed every day. * NIPS pain assessments of preterm babies will be performed after the procedure

Other: massage

control group

NO INTERVENTION

Follow-up form, pain and comfort scales will be applied simultaneously with the experimental group.

Interventions

massage OTHER

Hands will be washed with hand soap and rubbed with disinfectant before the procedure. * The head of the bed is raised by 30°-45° in the incubator. * The baby is placed face down. * Vaseline is applied to the hands. * The 15 minute session will consist of three 5 minute phases. Phase 1 will be tactile stimulation phase, Phase 2 will be kinesthetic stimulation and Phase 3 will be I Love You technique. * In the tactile stimulation phase, the infant is turned to the prone position and a stroking motion (12 strokes in approximately 5 seconds) will be applied with moderate pressure in 1-minute intervals, from the top of the head to the neck and back to the top of the head, from the neck to the shoulder, from the neck to the shoulder, from the upper back to the waist and back to the upper back, from the thigh to the foot and both legs, from the shoulder to the hand and from both arms to the shoulder. * In the kinesthetic stimulation phase, the infant is placed in the supine position and eac

massage group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants of parents who agreed to participate in the study,
• Receiving NCPAP therapy for at least 1 day,
• Gestational age greater than 32 weeks
• Birth weight over 1500 grams
• Infants fed with orogastric + total parenteral nutrition (TPN) will be included.

You may not qualify if:

• Infants with necrotising entecolitis, suspected or confirmed sepsis,
• No skin disease,
• Not receiving sedation (considering that it may affect pain response),
• Babies who have undergone surgical intervention (abdominal and central nervous system, cardiac surgery)
• Babies of substance-abusing mothers,
• Infants of parents who do not agree to participate in the study will not be included.
• Babies in the massage group who switched from Ncpap to IMV, who underwent surgical intervention with sedation and who developed NEC will be excluded from the study.

Sponsors & Collaborators

• Özlem BOZBUĞA: lead

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• EMİNE ERDEM

  TC Erciyes University

  STUDY CHAIR

• OZNUR BASDAS

  TC Erciyes University

  STUDY DIRECTOR

• SELVİ GULAŞI

  Adana City Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

ÖZLEM BOZBUGA

CONTACT

05434428326; ozlembozbuga5134@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Msc. Nurse

Model Details: This research will be carried out as a randomised controlled experimental study in a pretest-posttest design in order to examine the effect of massage on pain, comfort and nutritional status of preterm infants who received Ncpap in the neonatal intensive care unit. ClinicalTrials number will be obtained for the research.Preterm infants will be randomly assigned to the study groups according to gestational week at birth and gender using a computer programme (randomizer.org). Power analysis was used to calculate the sample size of the randomised controlled trial. G\*Power 3.1.9.7. programme with 95% power, 0.05 error margin and 2.23 effect size, the sample size was calculated as 12 people for each group. Considering the loss of data in the study, it was decided to include 15 people in each group. The reference study was used to determine the effect size \[16\]Preterm infants in the experimental and control groups will be selected similarly according to sex, birth weight, gestational week,

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 29, 2025
• Study Start: January 30, 2025
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share