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Completed

NCT Number: NCT07519291

EFFECTS OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Van, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy

Other

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.

Reflexology

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hakkari Universitesi

Other

Registry information

Official study title

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

Acronym: AROMA-REF CP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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