Effect of Reflexology on Pain Management in Newborns
Condition: Pain, Procedural; Pain, Acute; Analgesia
MeSH terms: Acute Pain; Pain, Procedural
Study type: Interventional

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.
    

Intervention name(s): Reflexology; Sucrose %24; Kangaroo care; Music
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): 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 newborns who were given one ml of a single-use 24% concentration of sucrose solution in the form of ready to use preparations; The newborns who were placed on the mother's lap for 3-5 minutes before the painful intervention and kangaroo care was applied; Newborns who were exposed to the recorded "Deep Sleep" track from "Bedtime Mozart: Classical Lullabies for Babies" music
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: newborn; pain management; crying; analgesics; reflexology