The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination

Sinem Basdemir

Status: Enrolling

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Other: Reverse Kangaroo Care Position; Other: ROP Position

Study type: Interventional

Funder types: Other

Identifiers

NCT06694103

EU-HEM-SB-01

Details and patient eligibility

About

The goal of this randomized controlled trial is to determine the effect of reverse kangaroo care position and ROP (Retinopathy of Prematurity) position applied during ROP examination in premature infants on pain. The main questions it aims to answer are as follows:

1. Is the reverse kangaroo care position effective in reducing the pain of premature infants during the ROP examination?
2. Is the reverse kangaroo care position more effective in reducing the pain of premature infants compared to the ROP position during the ROP examination?

Researchers will determine the effect of reverse kangaroo care position and ROP position applied during premature retinopathy examination in premature infants with a gestational age of less than 34 weeks on pain in infants.

• The infants of parents who volunteer to participate in the study will be divided into two groups as Reverse Kangaroo Care Position group and ROP Position group according to randomization.
• From the infants whose pupils are sufficiently mydriasis and are taken to the examination table, premature infants in the ROP Position group will be given ROP position together with the nurse and the parent.
• Premature infants in the Reverse Kangaroo Care Position group will be given reverse kangaroo care position.
• Video recording will be made during the given positions.
• The effects of the applied positions on pain will be determined as a result of the measured parameters before, during and after the examination.

Full description

• 84 premature infants that meet the sample criteria will be determined.
• Randomization will be performed and premature babies will be assigned to the Reverse Kangaroo Care Position (Group 1) and Rope Position (Group 2) groups.
• The purpose of the study will be explained to the mother by meeting her and written consent will be obtained.
• The Premature Identification Form, which includes information about the infant, will be filled out.

According to the groups to which the premature infants who were randomized were assigned;

One minute before the examination;

1. The infants will be placed on the examination table and one drop of %0.5 alcaine (proparacaine HCl) topical anesthetic eye drops will be applied to both eyes of the premature infantss assigned to both groups by the neonatal intensive care nurse.
2. The pulse oximetry probe will be attached to the infants' right feet and monitored.
3. The infants will be positioned according to the group they are assigned to.
4. Video recording will be started one minute before the examination and will continue until 1 minute after the examination.
5. In order to evaluate the SPO2, KTA, PIPP-R values of all groups at the 15th second before the examination, the infant will be recorded on video for one minute.

During the Examination; In the Reverse Kangaroo Care Position Group;

1. While the reverse kangaroo care position applied to the infants is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
2. The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation

In the ROP Position Group;

1. While the ROP position applied to the babies is maintained, the speculum is placed on the eye by the ophthalmologist and the video recording will continue throughout the examination from the moment the examination begins
2. The SPO2, KTA, PIPP-R in the 1st minute of the examination will be recorded for evaluation

At the end of the examination;

1. After the completion of both eye examinations, the video recording will continue for 1 more minute while the positions of the babies whose monitoring continues are maintained
2. The video recording will end 1 minute after the examination ends
3. The infant's SPO2, KTA, values, PIPP-R pain score will be evaluated and recorded
4. . The aim is to record the infant's SPO2 and KTA values at 30 seconds so that the PIPP-R pain score can be evaluated later.

Enrollment: 84 estimated patients

Sex: All

Ages: 28 to 33 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age <34 weeks,
• Birth weight ≤ 2500 grams,
• No painful interventions at least 1 hour before the ROP examination,
• Fed at least 1 hour before the ROP examination,
• Premature infants whose parents consented to participate in the study.

Exclusion criteria

• Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.)
• Any congenital anomaly (eye, neurological, etc.),
• Have a diagnosed hearing problem,
• A different painful procedure was performed at least one hour before the ROP examination,
• Administration of an analgesic/sedative medication before the examination,
• Premature infants whose parents did not consent to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Reverse Kangaroo Care Position Group

Experimental group

Description:

The advantages of kangaroo care will be utilised in the ROP examination. By reversing the position of the baby's face to the mother's breast, a change in the traditional kangaroo care posture will be applied, called the reverse kangaroo care position. Premature infants will be placed on the examination table for ROP examination and the infants' clothes other than diapers will be removed. Mothers will lie on the examination table by removing their upper clothes and their infants will be positioned in the inverted kangaroo care position, with the infant's back resting between the mother's bare chest. The privacy of the mother and the infant will be ensured and the infant will be able to smell the mother's scent with a piece of clothing taken off by the mother.

Treatment:

Other: Reverse Kangaroo Care Position

ROP Position Group

Experimental group

Description:

The position is given while the premature infant is in the supine position with the presence of two people (mother and nurse). It is performed in two stages by positioning the lower and upper extremities of the premature infant. The feet and legs are in the lower extremities, and the arms and head are in the upper extremities. During the examination, the premature infant's head is in slight hyperextension so that the retinal maneuvers applied by the ophthalmologist can be easily performed. The nurse places the infant's own palms on the temporal region and supports the head by holding it with her hands, while the mother supports the infant by bringing the infant's legs together and pushing it towards her abdomen.

Treatment:

Other: ROP Position