Clinical trial NCT05235893: Effect of Reflexology on Pain Management in Newborns
Official title: The Effect of Reflexology on Pain Management in Newborns: A Randomized-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Pain, Acute
Analgesia
Keywords: newborn
pain management
crying
analgesics
reflexology
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study was planned as a randomized controlled trial conducted between December 2019 and March 2020 in term babies being followed up in the 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 have not applied any analgesic method. All term infants were collected by the convenience sampling method from NICU and maternity ward according to inclusion and exclusion criteria. The parents of all participants were informed in detail about the study by investigator 1, and a copy of the informed consent form was delivered to the family. During the study period (December 2019 and March 2020), an average of 915 neonates per month was born in the same hospital. The participants who met the selection criteria and whose mothers agreed to participate in the study were recruited. A computer-generated block method assigned infants to receive either reflexology, 24% sucrose, kangaroo care, classic music, or control group. Term newborns hospitalized in the maternity ward and the NICU are randomly allocated to one of five groups, before the heel stick procedure by investigator 1 using a computer-generated table. For each participant, a random number was generated, and babies were subgrouped as follows: 1) Sucrose Group, 2) Reflexology Group, 3) Kangaroo Care Group, 4) Music Group, 5) Control Group, and the same randomization method was used to allocate the newborns before venous sampling. Sampling size was calculated as 27 per group and total number as 270 to obtain statistical significance with at least 85% power, and for an alpha significance level of 0.05 respectively in five groups. 30 newborns were allocated to each group for venous sampling (Total 150) and heel-prick (Total 150) intervention taking into account drop-out and other possible problems.

Interventions One ml of a single-use 24% concentration of sucrose solution in the form of ready-to-use preparations were given to the newborns in the first study group by the investigator 2, two minutes before the painful intervention. 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. The participants in the third study group were placed on the mother's lap for 3-5 minutes before the painful intervention and kangaroo care was applied. Participants in the fourth study group were exposed to the recorded music with sounds up to 60 A-weighted decibels, starting 20 minutes before the intervention, continuing for 7 minutes after the procedure. Music was administered using the "Deep Sleep" track from "Bedtime Mozart: Classical Lullabies for Babies" (2011), an instrumental lullaby music track chosen after discussion with a music therapist for stability, repeatability, and presence of minor tones. The piece of music was presented as a loop and was played back from a sound source using 2 high-quality portable speakers, placed equidistant from the head on each side. The sound levels at both ears were checked after speaker placement and the sound was gradually scaled up to the study limit of 60 A-weighted decibels. However, the total auditory exposure was checked to ensure that it remained within the recommended limits at the ear level.

Sampling procedures Heel pricks and venous blood collection were performed by an experienced nurse blinded to the applied non-pharmacological analgesic method (heel lance by nurse 1 / venous sampling by nurse 2). BD Quickheel Preemie lancet; Becton, Dickinson and Company, East Rutherford, NJ was used for heel lance. The blood-drawing procedure was conducted by an experienced newborn nurse in one attempt and the same amount of blood was taken from each newborn. The blood drawing site was the lateral surface of the right heel. During the data collection process, parents could observe their newborns in both the study and control groups. All interventions were made after all infants were followed up in the prone or side-lying position, feeding, and then cleaned in the NICU or maternity ward.

Pain Assessment Pain assessments, physiological and behavioral responses of participants were measured during the interventions. Behavioral responses and pain assessments of all newborn infants were evaluated with Neonatal Infant Pain Scale (NIPS) by 2 different investigator (3-4) before (2 minutes ago), during and after (after 2 minutes) interventions, and physiological changes were recorded by pulse oximetry (the Masimo Rad 5 Pulse Oximeter, Masimo Corporation, Irvine, CA). NIPS and other data were filled via video recordings by experienced NICU nurses and forms were sent by mail to the department to be analyzed, separately. NIPS was developed by Lawrence et al in 1993 to assess behavioral responses and physiologic pain responses of preterm and full-term newborns during acute pain and was adapted to the Turkish version by Akdovan in 1999. Lawrence et al. found the reliability coefficient of NIPS to be in the range of .92-.97. In addition, Akdovan reported the Cronbach's value to be between .83 and .86 in the Turkish version. The scale comprised five behavioral indicators (facial expressions, cry, state of arousal, arms, legs) and one physiologic indicator (breathing patterns). Except for ''cry,'' which had three possible score descriptors (0, 1, or 2), each behavioral indicator was scored with 0 or 1. The total score ranged between 0 and 7. High scores indicated higher levels of pain. An oximeter was secured to the participants before the intervention and peak heart rates and oxygen saturation values were obtained. The probe of the pulse oximeter was attached to the left foot of the newborns and was fixed so that it would remain in place. Heartbeat (HR), respiratory rate (RR), body temperature (BT), blood pressure (systolic blood pressure (BPs), diastolic blood pressure (DBp), mean arterial pressure (MAP), oxygen saturation (SpO2) values were recorded on the follow-up form.

Ethical approval: The study was approved by the ethics committee of the Local Health District with decision number: 2019-25-02 at 23.12.2019. Informed written consent was obtained from the parents before recruitment.

Statical Analysis Statistical Package for the Social Sciences (SPSS 15.0) for Windows program was used for statistical analysis. Descriptive statistics; number and percentage for categorical variables, and numerical variables as mean, standard deviation, minimum, maximum, median. Since the numerical variables did not meet the normal distribution condition, comparisons of two independent groups were made with the Mann-Whitney U Test. Since the differences of numerical variables in the dependent groups did not meet the normal distribution condition, they were compared with the Wilcoxon test. Inter-rater reliability bias was evaluated with the Intraclass Correlations (ICC) level. Bonferroni's correction was used to evaluate inter-method efficacy and a one-way ANOVA test was used to investigate more than 2 independent variables. Statistical alpha significance level was accepted as p\<0.05.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Effect of Reflexology on change in pain perception during painful procedures in Newborns
timeFrame: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions
measure: Effect of Reflexology on crying time during painful procedures in Newborns
timeFrame: from beginning of the painful intervention until crying stops measured in minutes
measure: Effect of Reflexology on change in blood pressure during painful procedures in Newborns
timeFrame: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions
measure: Effect of Reflexology on change in oxygen saturation during painful procedures in Newborns
timeFrame: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions
Secondary outcomes:
measure: Effect of Reflexology on change in heart rate during painful procedures in Newborns
timeFrame: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions
measure: Effect of Reflexology on change in respiratory rate during painful procedures in Newborns
timeFrame: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Esenler Maternity and Child Health Hospital
state: Esenler
Study officials:
affiliation: Esenler Maternity and Child Health Hospital
name: Mahmut Caner US, MD
role: PRINCIPAL_INVESTIGATOR
References:
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