HealthyNCT04467645
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
A study testing reflexology in people with Healthy and Nursing Caries, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nursing Caries
- What is being tested?
- reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 28 Sep 2019
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to communicate,
- aged 50 to 65,
Who cannot join
- taking hormone replacement therapy,
- chronic diseases (such as diabetes, hypertension, and so on),
- psychiatric disease,
- diagnosed with a sleep disorder attributed to other cause
- menstruation for more than one year
- history of alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial
Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.
Read the detailed description
This study was conducted in Batıkent Family Health Center of the Ministry of Health between May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal women by the researcher twice a week. No intervention was applied to the postmenopausal women in the control group.
- Conditions
- Healthy, Nursing Caries
- Being tested
- reflexology
- Keywords
- Nurse, postmenopausal women, sleep, reflexology, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexologyOther
Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Reflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient. Receives: Other: reflexology |
| No intervention | No intervention | No intervention was applied to the postmenopausal women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
A PSQI score of 5 or higher indicates poor sleep quality. A mean total score on the FSS of four and above indicates chronic fatigue.
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 May 2018
- Primary completion30 Dec 2018
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla ZENGİN AYDIN, Dicle University
- Investigators
- Leyla ZENGİN AYDIN, Principal investigator, Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467645
- Sponsor's protocol ID
- LZA2018/4
- Status last verified
- Jul 2020
- First submitted
- 24 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04467645
- Acronym / sponsor ID
- LZA2018/4
- Conditions
- Healthy, Nursing Caries
- Keywords
- Nurse, postmenopausal women, sleep, reflexology, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 13 Jul 2020 (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.
Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.
Detailed description
This study was conducted in Batıkent Family Health Center of the Ministry of Health between May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal women by the researcher twice a week. No intervention was applied to the postmenopausal women in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Other: reflexologyReflexology Application: A total of twelve 30-minute reflexology sessions (2 per week)were administered to each patient. |
| No intervention | No intervention | –No intervention was applied to the postmenopausal women in the control group. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to communicate,
- aged 50 to 65,
Key exclusion criteria (6 listed)
- taking hormone replacement therapy,
- chronic diseases (such as diabetes, hypertension, and so on),
- psychiatric disease,
- diagnosed with a sleep disorder attributed to other cause
- menstruation for more than one year
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 |
|---|---|---|
| reflexologyReflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body. | Other | Reflexology |
Primary outcome
Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
Time frame: first week
A PSQI score of 5 or higher indicates poor sleep quality. A mean total score on the FSS of four and above indicates chronic fatigue.
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 Jul 2020.
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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.
Leyla ZENGİN AYDIN principal investigator
Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology in people with Healthy and Nursing Caries, run by Dicle 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 2 inclusion and 6 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 Jul 2020. 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?
Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS). (time frame: first week). 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 Jul 2020.