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The Effect of Massage on Preterm Babies

ConditionsPreTerm NeonatenCPAPMassage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-37
SponsorÖzlem BOZBUĞA

About this trial

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...)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

• 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • massage

    Other intervention

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: massage groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
5 day
2

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

Time frame
5 day
3

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

Time frame
5 day

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Özlem BOZBUĞA

Lead sponsor

TC Erciyes University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: