NCT07519291

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 2, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

aromatherapyreflexologypainsleepparental satisfactionpublic health nursing

Outcome Measures

Primary Outcomes (2)

  • Pain Level

    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

    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 Outcomes (1)

  • Parental Satisfaction

    After 4 weeks of intervention

Study Arms (3)

Aromatherapy Group

EXPERIMENTAL

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

Reflexology Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Aromatherapy Group

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.

Reflexology Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Education and Rehabilitation Centers affiliated with the Ministry of National Education

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyPainSleep Wake Disorders

Interventions

AromatherapyMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and ActivitiesPhysical Therapy ModalitiesRehabilitation

Study Officials

  • SAMET KOLTAŞ, Lecturer PhD

    Hakkari Uviversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study was conducted as an open-label trial. Due to the nature of the interventions (aromatherapy and reflexology), blinding of participants and care providers was not feasible.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to three parallel groups: aromatherapy, reflexology, and control. Each group received its respective intervention simultaneously, and outcomes were assessed before and after the intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (PhD)

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations