Assessing the effectiveness of touch intervention for pain control during examination for retinopathy of prematurity

Not Applicable

Completed

• Conditions: Retinopathy of prematurity; Eye Diseases

• Registration Number: ISRCTN10976481
• Lead Sponsor: anjing Medical University

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33425819/ (added 12/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-30
• Study Start: 2020-03-06
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Premature birth with a gestational age of =34 weeks or a birth weight of =2000 g
2. No prior history of fundus screening
3. Screening at 4 to 6 weeks of age after birth or a corrected gestational age of 31 to 32 weeks

Exclusion Criteria

1. Administration of nonsteroidal anti-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital, and diazepam within 24 hours before ROP screening
2. Intolerance to screening because of critical conditions like severe respiratory diseases, central nervous system infections, sepsis, and other organic diseases such as severe congenital heart malformation and pulmonary insufficiency
3. Unsuitable conditions during ROP screening, such as severe coughing and shortness of breath

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The degree of pain during the examination quantified using the Premature Infant Pain Profile (PIPP). The PIPP assessment items include the gestational age, increased HR, decreased blood oxygen saturation (SaO2), a state of arousal, and the proportion of painful expressions throughout the examination (frowning, blinking, and wrinkling the nose and sulcus). There are a total of seven items, each of which is scored on a scale of 0–3. The total PIPP score is calculated as the sum of the scores for all seven items, and the maximum score is 21 points. A higher score indicates greater pain severity. The video camera is positioned for a closeup of the face. The signals were fed directly to a VCR during the painful procedure.

Secondary Outcome Measures

Name	Time	Method
Heart rate (HR), SaO2, and rScO2: an EGOS-600A NIRS meter (EnginMed, Suzhou, China) is used to collect data for the regional cerebral oxygen saturation (rScO2) before and during screening. Before screening, the NIRS probe is placed at the center of the forehead. The recorder traces a 2-min curve in the quiet state, and the stable value displayed after the curve represented the oxygen saturation of the basal brain tissue, which is then compared with the tissue oxygen saturation recorded at the time of pain during ROP screening. At the same time, a pulse oximeter (Comen Medical Instruments, Shenzhen, China) is used to measure SaO2 and HR. For calculation of the PIPP score, the infant’s facial expressions and pulse oximetry findings are recorded throughout the procedure.