Cerebral Palsy (CP)AROMA-REF CPNCT07519291
EFFECTS OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY
A study testing Aromatherapy and Reflexology in people with Cerebral Palsy (CP) and Pain, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Pain, Sleep Disorder (Disorder)
- What is being tested?
- Aromatherapy and Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Special Education and Rehabilitation Centers affiliated with the Ministry of National Education
Van
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP), Pain, Sleep Disorder (Disorder)
- Being tested
- Aromatherapy, Reflexology
- Keywords
- aromatherapy, reflexology, pain, sleep, parental satisfaction, public health nursing
- Medical subject headings
- Cerebral Palsy, Pain, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
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.
ReflexologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks after intervention
Secondary outcomes (1)
Parental Satisfaction
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.
Measured: After 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samet Koltaş, Hakkari Universitesi
- Investigators
- SAMET KOLTAŞ, Lecturer PhD, Principal investigator, Hakkari Uviversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519291
- Sponsor's protocol ID
- HU-SHMYO-SK-02
- Acronym
- AROMA-REF CP
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations, as well as institutional and ethical restrictions regarding data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF AROMATHERAPY AND REFLEXOLOGY ON PAIN, SLEEP QUALITY, AND SATISFACTION IN CHILDREN WITH CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07519291
- Acronym / sponsor ID
- AROMA-REF CP / HU-SHMYO-SK-02
- Conditions
- Cerebral Palsy (CP), Pain, Sleep Disorder (Disorder)
- Keywords
- aromatherapy, reflexology, pain, sleep, parental satisfaction, public health nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Group | Experimental | Other: AromatherapyParticipants 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. |
| Reflexology Group | Experimental | Other: ReflexologyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyLavender 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. | Other | Aromatherapy Group |
| ReflexologyManual 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. | Other | Reflexology Group |
Primary outcome
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.
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.
1 secondary outcome
Parental Satisfaction
Time frame: After 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations, as well as institutional and ethical restrictions regarding data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAMET KOLTAŞ, Lecturer PhD principal investigator
Hakkari Uviversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Reflexology in people with Cerebral Palsy (CP) and Pain, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Baseline and 4 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.