Swaddle and/or sucrose role in the pain control during eye examination

Comparing the effect of swaddle and sucrose combination with unique effect of both swaddle, sucrose or placebo on the control of pain secondary to retinopathy of prematurity examination of premature neonates

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014122610279N5

Enrollment

Registered

2015-02-24

Start date

2010-12-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity. Retinopathy of prematurity

Interventions

Intervention 1: Neonates who were given distilled water 2 minutes before the procedure. Intervention 2: Neonates who were swaddled 15 minutes before the procedure. Intervention 3: Neonates who were gi

Placebo

Neonates who were given distilled water 2 minutes before the procedure

Neonates who were swaddled 15 minutes before the procedure

Neonates who were given 0.6 ml 24% sucrose 2 minutes before the procedure.

Neonates who were swaddled 15 minutes before the procedure and who were given 0.6 ml 24% sucrose 2 minutes before the procedure.

Eligibility

Sex/Gender

All

Age

28 Days to 2 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria; 1. Premature neonates who underwent first retinopathy of prematurity examination. Exclusion criteria; 1. Invasive or noninvasive mechanical ventilation therapy during retinopathy of prematurity examination. 2. Neonates who take analgesia, sedative medicine. 3. Asphyxia 4. Intraventricular hemorrhage 5. Neonates who were resuscitated 6. Neonates who had congenital anomaly

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Premature infant pain scale (PIPP). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.	—

Secondary

Measure	Time frame
Crying time. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Desaturation (180 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Degree of cry. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.	—

Measure

Time frame

Crying time. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Desaturation (180 bpm). Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.;Degree of cry. Timepoint: 30th and 60th second, 2nd minute for both eye examination, also 4th minute for right eye examination. Method of measurement: Video records.

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Countries

Turkey

Contacts

Public ContactDerya Benzer

Zeynep Kamil Maternity and Children's Education and Training Hospital

dbenzer@yahoo.com0090 216 391 06 80

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026