Effect of Reflexology on Pain Management in Newborns

NCT05235893 | Completed DMC

• 1 other identifier: 2019/406
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Approximately 10-14 painful procedures per day are performed in preterm and term infants during the hospital stay in the first week. The investigators aimed to determine the effect of reflexology being applied to the sole during painful procedures on pain perception, behavioral responses, and physiological changes in newborns compared with other non-pharmacological methods. Material and Method: This study was planned as a randomized controlled trial in term infants being followed up in the Neonatal Intensive Care Unit (NICU) and maternity ward. To reduce pain during attempts to collect venous blood or heel lance which are routinely applied to term newborns before discharge; reflexology on the soles of the foot, 24% sucrose solution, kangaroo care, listening to classical music were applied to the babies and were compared to those who did not have any analgesic method.

Conditions

Pain, Procedural; Pain, Acute; Analgesia

Keywords

newborn; pain management; crying; analgesics; reflexology

Outcome Measures

Primary Outcomes (4)

• Effect of Reflexology on change in pain perception during painful procedures in Newborns

  To evaluate the effect of reflexology on pain perception, Neonatal Infant Pain Scale was scored and compared with other non-pharmacological methods outcomes. Scoring was obtained 2 minutes before, during, and 2 minutes after the painful intervention in babies aged 2 to 28 days, before discharge from hospital. The Neonatal Infant Pain Scale consists of five behavioral sections and one physiological section including facial expression, crying, breathing, arm, and leg movements, and alertness. Total scores for each section range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicate mild to moderate pain, and \> 4 indicates severe pain. Higher scores indicate more severe pain. Change from Baseline of Neonatal Infant Pain Scale score was assesed.

  2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

• Effect of Reflexology on crying time during painful procedures in Newborns

  To evaluate the effect of reflexology on behavioural responses, crying time (minute) was noted and compared with other non-pharmacological methods outcomes. During the painful procedures in babies aged 2 to 28 days, crying time was observed by using a chronometer and noted as minutes and seconds. Higher minutes indicate more severe pain.

  from beginning of the painful intervention until crying stops measured in minutes

• Effect of Reflexology on change in blood pressure during painful procedures in Newborns

  To evaluate the effect of reflexology on physiological parameters a monitor was used to measure blood pressure (systolic, diastolic, mean arterial pressure; mmHg) and compared with other nonpharmacological methods outcomes. Measurements were obtained 2 minutes before, during, and 2 minutes after the painful intervention in babies aged 2 to 28 days, before discharge from the hospital. Change from the Baseline of blood pressure (systolic, diastolic, mean arterial pressure; mmHg) were assessed.

  2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

• Effect of Reflexology on change in oxygen saturation during painful procedures in Newborns

  To evaluate the effect of reflexology on physiological parameters a monitor was used to oxygen saturation (%), and compared with other nonpharmacological methods outcomes. Measurements were obtained 2 minutes before, during, and 2 minutes after the painful intervention in babies aged 2 to 28 days, before discharge from the hospital. Change from the Baseline of oxygen saturation (%) was assessed.

  2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

Secondary Outcomes (2)

• Effect of Reflexology on change in heart rate during painful procedures in Newborns

  2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

• Effect of Reflexology on change in respiratory rate during painful procedures in Newborns

  2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

Study Arms (5)

Reflexology Group

EXPERIMENTAL

The newborns who have applied Reflexology to soles three minutes before and during 5-7 minutes of painful procedure by a physiotherapist, certificated in reflexology.

Procedure: Reflexology

Sucrose Group

ACTIVE COMPARATOR

The newborns who were given one ml of a single-use 24% concentration of sucrose solution in the form of ready to use preparations

Procedure: Sucrose %24

Kangaroo Care Group

ACTIVE COMPARATOR

The newborns who were placed on the mother's lap for 3-5 minutes before the painful intervention and kangaroo care was applied

Procedure: Kangaroo care

Music Group

ACTIVE COMPARATOR

Newborns who were exposed to the recorded "Deep Sleep" track from "Bedtime Mozart: Classical Lullabies for Babies" music

Procedure: Music

Control Group

NO INTERVENTION

Control arm

Interventions

Reflexology PROCEDURE

Reflexology was applied to soles of the babies in the second study group during 5-7 minutes, three minutes before the painful procedure was started by a physiotherapist, certificated in reflexology.

Reflexology Group

Sucrose %24 PROCEDURE

The newborns who were given one ml of a single-use 24% concentration of sucrose solution in the form of ready to use preparations

Sucrose Group

Kangaroo care PROCEDURE

The newborns who were placed on the mother's lap for 3-5 minutes before the painful intervention and kangaroo care was applied

Kangaroo Care Group

Music PROCEDURE

Newborns who were exposed to the recorded "Deep Sleep" track from "Bedtime Mozart: Classical Lullabies for Babies" music

Music Group

Eligibility Criteria

• Age: 2 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns who are hospitalized in the NICU and maternity ward who will undergo heel lance or venous blood sampling before discharge.
• Those who meet the discharge criteria recommended in the TNS guideline
• Approved family informed consent.

You may not qualify if:

• Infants born with a birth weight below 2500 g and over 4000 g
• Infants born before 37 gestational weeks,
• Presence of major congenital anomaly or neurological problems.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Esenler Maternity and Child Health Hospital

Istanbul, Esenler, 34230, Turkey (Türkiye)

Location

Related Publications (7)

• Huang RR, Xie RH, Wen SW, Chen SL, She Q, Liu YN, Harrison D. Sweet Solutions for Analgesia in Neonates in China: A Systematic Review and Meta-Analysis. Can J Nurs Res. 2019 Jun;51(2):116-127. doi: 10.1177/0844562118803756. Epub 2018 Nov 22.

  PMID: 30466313 BACKGROUND

• Benoit B, Martin-Misener R, Latimer M, Campbell-Yeo M. Breast-Feeding Analgesia in Infants: An Update on the Current State of Evidence. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):145-159. doi: 10.1097/JPN.0000000000000253.

  PMID: 28437305 BACKGROUND

• Hall RW, Anand KJ. Pain management in newborns. Clin Perinatol. 2014 Dec;41(4):895-924. doi: 10.1016/j.clp.2014.08.010. Epub 2014 Oct 7.

  PMID: 25459780 BACKGROUND

• Yilmaz D, Yilmaz Kurt F. The effect of foot reflexology on procedural pain before heel lancing in neonates. Arch Pediatr. 2021 May;28(4):278-284. doi: 10.1016/j.arcped.2021.02.015. Epub 2021 Mar 11.

  PMID: 33715931 BACKGROUND

• Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

  PMID: 8413140 BACKGROUND

• Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6.

  PMID: 21048258 BACKGROUND

• Us MC, Saran MG, Cebeci B, Akkus E, Seker E, Aybar SSS. A Randomized Comparative Effectiveness Study of Reflexology, Sucrose, and Other Treatments for Needle Procedures in Newborns. Pediatr Neurol. 2023 Mar;140:78-85. doi: 10.1016/j.pediatrneurol.2022.11.019. Epub 2022 Dec 5.

  PMID: 36608413 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Acute Pain; Agnosia; Crying

Interventions

Musculoskeletal Manipulations; Kangaroo-Mother Care Method; Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Patient Positioning; Patient Care; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Sensory Art Therapies; Aftercare; Continuity of Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mahmut Caner US, MD

  Esenler Maternity and Child Health Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student, Principal Investigator

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: February 11, 2022
• Study Start: December 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)