Stroke, IschemicNCT05403515
Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
A study testing foot massage and Foot massage +Aromatherapy group in people with Stroke, Ischemic, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world. Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- foot massage and Foot massage +Aromatherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Oct 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem
Who cannot join
- Exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the Turkish language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world.
Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke.
Material and method: The present study is a randomized clinical study with a control group. Participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke. The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire, Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted using frequency tables and descriptive statistics. Foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.
- Conditions
- Stroke, Ischemic
- Being tested
- foot massage, Foot massage +Aromatherapy group
- Keywords
- Foot massage, Aromatherapy massage, Happiness, Sleep quality, Fatigue
- Medical subject headings
- Ischemic Stroke, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot massageOther
foot massage
Foot massage +Aromatherapy groupOther
foot massage and lavender oil inhalation
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine nursing interventions were performed on the patients. |
| Foot massage group: | Experimental | For the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. For the patients in foot massage group, 30-min foot massage sessions (15 min for each foot, 3 sessions per week for 1 month) were performed in a special room of rehabilitation center, in a quiet atmosphere at suitable temperature and without environmental stimulants. Receives: Other: foot massage |
| Foot massage +Aromatherapy group: | Experimental | For the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. During the foot massage + aromatherapy lavender inhalation intervention, the patients were given lavender oil for 30 minutes by using a censer. The intervention protocol was developed reviewing the literature about lavender oil inhalation Receives: Other: Foot massage +Aromatherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot massage changes improves happiness and sleep quality.
Oxford Happiness Questionnaire - Short Form (OHQ - S) The total score ranges between 7 and 35 points.
Pittsburgh Sleep Quality Index (PSQI):
To identify the sleep is good or bad, PSQI quantitatively measures the quality of sleep. It includes a total of 24 items. Total score of 0-4 points indicates a good sleep quality and the scores between 5 and 21 indicate a poor sleep quality Piper Fatigue Scale Developed by Piper et al. (1998), this scale consists of 24 items and assesses 4 subjective dimensions of fatigue. Reliability and validity of Piper Fatigue Scale for Turkish society were tested by Can (2001). The mean score of 0 point indicates that there was no fatigue, whereas mean scores between 1 and 3 indicate a mild level of fatigue, those between 4 and 6 indicate a moderate level of fatigue, and those between 7 and 10 indicate a severe level of fatigue
Measured: 1 month
Secondary outcomes (1)
Lavender oil inhalation changes happiness and sleep quality
Oxford Happiness Questionnaire - Short Form (OHQ - S) The total score ranges between 7 and 35 points.
Pittsburgh Sleep Quality Index (PSQI):
To identify the sleep is good or bad, PSQI quantitatively measures the quality of sleep. It includes a total of 24 items. Total score of 0-4 points indicates a good sleep quality and the scores between 5 and 21 indicate a poor sleep quality Piper Fatigue Scale Developed by Piper et al. (1998), this scale consists of 24 items and assesses 4 subjective dimensions of fatigue. Reliability and validity of Piper Fatigue Scale for Turkish society were tested by Can (2001). The mean score of 0 point indicates that there was no fatigue, whereas mean scores between 1 and 3 indicate a mild level of fatigue, those between 4 and 6 indicate a moderate level of fatigue, and those between 7 and 10 indicate a severe level of fatigue
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Sevgi Ünal Aslan, Osmaniye Korkut Ata University
- Investigators
- Kevser Sevgi Ü ASLAN, Principal investigator, OSMANİYE KORKUT ATA UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403515
- Sponsor's protocol ID
- Osmaniye Korkut Ata Unıvesity
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data can be shared if the author gives consent for appropriate reasons.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aromatherapy and Foot Massage on Happiness, Sleep Quality, and Fatigue Levels of Patients With Stroke
- ClinicalTrials.gov ID
- NCT05403515
- Acronym / sponsor ID
- Osmaniye Korkut Ata Unıvesity
- Conditions
- Stroke, Ischemic
- Keywords
- Foot massage, Aromatherapy massage, Happiness, Sleep quality, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Jun 2022 (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.
Background: Stroke puts important economic and social loads on the society and was reported to be the most important reason for disability throughout the world.
Purpose: The present study aims to experimentally examine the effect of aromatherapy and foot massage on happiness, sleep quality, and fatigue levels of patients with stroke.
Material and method: The present study is a randomized clinical study with a control group. Participants were randomly divided into three groups (foot massage + aromatherapy, aromatherapy, and control). The study was carried out with 91 patients diagnosed with stroke. The data were collected using Sociodemographic Status Survey, Oxford Happiness Questionnaire, Piper Fatigue Scale, Pittsburgh Sleep Quality Index (PSQI). Statistical analyses were performed using SPSS (IBM SPSS Statistics 24) package program. The results were interpreted using frequency tables and descriptive statistics. Foot massage group was given 30min foot massage sessions (3 days per week) for 4 weeks, whereas foot massage + aromatherapy group was given lavender oil inhaler during the foot massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine nursing interventions were performed on the patients. |
| Foot massage group: | Experimental | Other: foot massageFor the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. For the patients in foot massage group, 30-min foot massage sessions (15 min for each foot, 3 sessions per week for 1 month) were performed in a special room of rehabilitation center, in a quiet atmosphere at suitable temperature and without environmental stimulants. |
| Foot massage +Aromatherapy group: | Experimental | Other: Foot massage +Aromatherapy groupFor the patients in this group, sociodemographic form, happiness questionnaire, and PSQI was applied as pretest in preliminary examination. The final examination was performed 1 month later (posttest) by using the same scale. During the foot massage + aromatherapy lavender inhalation intervention, the patients were given lavender oil for 30 minutes by using a censer. The intervention protocol was developed reviewing the literature about lavender oil inhalation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were diagnosis of stroke at least 3 months, stroke levels of mild or moderate, no use of sleeping pill, volunteering in participation, not being allergic to aromatic oils, no problem with sense of smell, and no lung problem
Key exclusion criteria (1 listed)
- Exclusion criteria were ulceration or lesion problem in foot, bone deformation in foot, history of allergy, cognitive or mental or language problems, difficulty in verbal communication, psychotic disorders, and not knowing the Turkish language.
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 |
|---|---|---|
| foot massagefoot massage | Other | Foot massage group: |
| Foot massage +Aromatherapy groupfoot massage and lavender oil inhalation | Other | Foot massage +Aromatherapy group: |
Primary outcome
foot massage changes improves happiness and sleep quality.
Time frame: 1 month
Oxford Happiness Questionnaire - Short Form (OHQ - S) The total score ranges between 7 and 35 points. Pittsburgh Sleep Quality Index (PSQI): To identify the sleep is good or bad, PSQI quantitatively measures the quality of sleep. It includes a total of 24 items. Total score of 0-4 points indicates a good sleep quality and the scores between 5 and 21 indicate a poor sleep quality Piper Fatigue Scale Developed by Piper et al. (1998), this scale consists of 24 items and assesses 4 subjective dimensions of fatigue. Reliability and validity of Piper Fatigue Scale for Turkish society were tested by Can (2001). The mean score of 0 point indicates that there was no fatigue, whereas mean scores between 1 and 3 indicate a mild level of fatigue, those between 4 and 6 indicate a moderate level of fatigue, and those between 7 and 10 indicate a severe level of fatigue
1 secondary outcome
Lavender oil inhalation changes happiness and sleep quality
Time frame: 1 month
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 3 Jun 2022.
- Individual participant dataSharing planned: Undecided. The data can be shared if the author gives consent for appropriate reasons.
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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.
Kevser Sevgi Ü ASLAN principal investigator
OSMANİYE KORKUT ATA UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot massage and Foot massage +Aromatherapy group in people with Stroke, Ischemic, run by Osmaniye Korkut Ata University 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 1 inclusion and 1 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 3 Jun 2022. 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?
foot massage changes improves happiness and sleep quality. (time frame: 1 month). 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 3 Jun 2022.