EFFECTS OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY (AROMA-REF CP)

April 8, 2026 updated by: Samet Koltaş, Hakkari Universitesi

THE EFFECT OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP QUALITY, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL

This randomized controlled trial was conducted to evaluate the effects of aromatherapy and foot reflexology on pain, sleep quality, and parental satisfaction in children with cerebral palsy. Cerebral palsy is a non-progressive neurodevelopmental disorder often associated with chronic pain and sleep disturbances, which negatively affect both children and their caregivers.

A total of 90 children aged 6-12 years with a confirmed diagnosis of cerebral palsy were randomly assigned to three groups: aromatherapy, reflexology, and control. The aromatherapy group received lavender oil massage applied to the feet, while the reflexology group received targeted pressure to specific reflex points on the feet. The control group did not receive any intervention. Interventions were applied over a defined period, and outcomes were measured before and after the intervention.

Pain levels, sleep quality, and parental satisfaction were assessed using validated measurement tools. The findings of this study aim to provide evidence on the effectiveness of non-invasive complementary therapies in improving clinical and caregiving outcomes in children with cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy (CP) is one of the most common causes of motor disability in childhood and is frequently accompanied by secondary complications such as chronic pain and sleep disturbances. These problems significantly affect the quality of life of both children and their caregivers. Managing these symptoms is essential for improving overall well-being and enhancing care outcomes.

Complementary and alternative therapies, such as aromatherapy and reflexology, have gained increasing attention in pediatric rehabilitation due to their non-invasive, low-cost, and easy-to-apply nature. Aromatherapy involves the use of essential oils, such as lavender oil, which are known for their analgesic, sedative, and anxiolytic properties. Reflexology is a manual therapy that applies pressure to specific points on the feet believed to correspond to different body systems, promoting relaxation and physiological balance.

This study was designed as a pretest-posttest randomized controlled trial. The study population consisted of children aged 6-12 years diagnosed with cerebral palsy and their primary caregivers. Participants were recruited from special education and rehabilitation centers affiliated with provincial education authorities. A total of 90 participants were randomly assigned into three groups: aromatherapy (n=30), reflexology (n=30), and control (n=30).

In the aromatherapy group, lavender oil was applied through foot massage. In the reflexology group, pressure was applied to specific reflex points on the soles of the feet. The control group did not receive any intervention. All interventions were implemented according to a structured protocol over a defined period.

Data were collected using a Personal Information Form, the Wong-Baker FACES Pain Rating Scale, the Children's Sleep Habits Questionnaire, and the Newcastle Satisfaction with Nursing Care Scale. Measurements were conducted before and after the intervention period.

The primary outcomes of the study were pain level and sleep quality, while parental satisfaction was evaluated as a secondary outcome. This study contributes to the evidence base regarding the effectiveness of complementary therapies in pediatric nursing care and supports the integration of holistic and family-centered approaches in the management of children with cerebral palsy.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Van, Turkey (Türkiye)
        • Special Education and Rehabilitation Centers affiliated with the Ministry of National Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children diagnosed with cerebral palsy by a specialist physician
  • Aged 6 to 12 years
  • Having pain complaints or being suitable for pain assessment
  • Having sleep problems or being suitable for sleep quality evaluation
  • Parents willing to participate and providing written informed consent
  • No health condition or history of allergic reactions preventing participation in aromatherapy or reflexology
  • Ability to regularly participate in the intervention sessions

Exclusion Criteria:

  • Known allergic reaction to essential oils used in aromatherapy
  • Presence of skin integrity issues, infection, or orthopedic problems preventing reflexology
  • Significant neurological changes during the study period, such as increased seizure frequency
  • Inability to regularly attend intervention sessions or withdrawal from the study
  • Incomplete or incorrectly filled data collection forms
  • Voluntary withdrawal of the child or parent from the study
  • Initiation of another complementary therapy or pharmacological change that may affect study outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy Group
Participants in this group received aromatherapy intervention using lavender essential oil applied through foot massage. The intervention was administered according to a structured protocol over the study period. The aim was to reduce pain, improve sleep quality, and increase parental satisfaction in children with cerebral palsy.
Other: Aromatherapy
Lavender essential oil was applied through foot massage according to a structured protocol. The intervention aimed to promote relaxation, reduce pain, and improve sleep quality in children with cerebral palsy.
Experimental: Reflexology Group
Participants in this group received foot reflexology, which involved applying manual pressure to specific reflex points on the soles of the feet. The intervention was implemented according to a structured protocol throughout the study period to reduce pain, improve sleep quality, and increase parental satisfaction in children with cerebral palsy.
Other: Reflexology
Manual pressure was applied to specific reflex points on the soles of the feet according to a structured protocol. The intervention aimed to reduce pain and improve sleep quality in children with cerebral palsy.
No Intervention: Control Group
Participants in this group did not receive any intervention during the study period. They continued with their usual care and were assessed using the same outcome measures as the intervention groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: Baseline and 4 weeks after intervention
Pain levels were assessed using the Wong-Baker FACES Pain Rating Scale, a validated tool ranging from 0 to 10. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. Higher scores indicate greater pain severity.
Baseline and 4 weeks after intervention
Sleep Quality
Time Frame: Baseline and 4 weeks after intervention
Sleep quality was evaluated using the Children's Sleep Habits Questionnaire (CSHQ). The total score ranges from 33 to 99, with higher scores indicating poorer sleep quality.
Baseline and 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Satisfaction
Time Frame: After 4 weeks of intervention
Parental satisfaction was measured using the Newcastle Satisfaction with Nursing Care Scale (NSNS). The scale ranges from 0 to 100, with higher scores indicating higher satisfaction with nursing care.
After 4 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hakkari Universitesi

Investigators

  • Principal Investigator: SAMET KOLTAŞ, Lecturer PhD, Hakkari Uviversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-SHMYO-SK-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations, as well as institutional and ethical restrictions regarding data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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