Nurse-Patient RelationsNCT06217497
The Effect of Foot Massage in Patients Undergoing Hemodialysis
A study testing Foot massage in people with Nurse-Patient Relations, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- Foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2021to 10 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a PSQI score of 5 points and above
- Receiving HD treatment for at least 6 months
- Having no neuropathy d) Using no sleeping pills
- Having no communication problem
- Having full orientation and no psychiatric problems
- Having no conditions in the lower extremities and feet that would preclude massaging (no open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.)
- Having no history of allergy to the oil used for massage.
Who cannot join
- Receiving less than 6 months of HD treatment
- Having communication problem
- Suffering from neuropathy
- Having incomplete orientation and any psychiatric problem
- Having a PSQI score below 5
- Having conditions in the lower extremities and feet that would preclude massaging (open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.) and having a history of allergy to the oil used for massage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Massage Applied to Patients Undergoing Hemodialysis on Sleep Quality and Fatigue Level:Randomized Controlled Study
Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.
Read the detailed description
An experimental study design was used to conduct this research on 73 hemodialysis patients treated in a hemodialysis unit. The aim of this study is to investigate how foot massage applied to hemodialysis patients affects sleep quality and fatigue level.
- Conditions
- Nurse-Patient Relations
- Being tested
- Foot massage
- Keywords
- Foot Massage, Hemodialysis, Nursing, Sleep Quality, Fatigue
- Medical subject headings
- 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
Patients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | After the patients in the experimental group were informed verbally and in writing and consented to participate in the study, the Patient Information Form, the Piper Fatigue Scale (PFS), and the Pittsburgh Sleep Quality Index (PSQI) were applied in the first interview and the initial readings were obtained. The researcher received training on a classical massage from an expert massage therapist before the foot massaging application. Patients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI. Receives: Other: Foot massage |
| Control Group | No intervention | Patients in the control group were not subjected to any intervention other than routine HD treatment and nursing care. The first readings were obtained by applying the Patient Information Form, PFS and PSQI at the first interview, and the second and third measurement values were obtained by repeating the PFS and PSQI at the end of the second and fourth weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper fatigue scale
Piper Fatigue Scale (PFS) was developed by Piper et al. The scale consists of a total of 22 items. Each item is rated over 0-10 points through Visual Analogue Scale (VAS) under four subscales related to the patient's subjective perception of fatigue. The behavioural subscale consists of 6 items (2-7), the affective subscale consists of 5 items (8-12), the sensory subscale consists of 5 items (13-17), and the cognitive subscale consists of 6 items [18-23]. Total fatigue score and subscale scores are calculated over 22 items. Items 1, 24, 25, 26 and 27 in the scale are not used in calculating the fatigue score. Total fatigue score is obtained by summing the items and dividing the resultant value by the total number of items, and subscale scores are obtained by summing the scores of all items in that subscale and dividing the resultant value by the number4 of items.
Measured: Last 2 weeks and last 4 weeks
Secondary outcomes (1)
Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse et al., . Turkish validity and reliability study of the scale was conducted by Ağargün et al.,. The index, which evaluates sleep quality, sleep duration, sleep latency, sleep disturbance and severity in the last 4 weeks, consists of a total of 24 items. 19 items in the index are self-assessment questions, the last 5 questions are answered by the individual's roommate or spouse, and the last 5 questions are not included in the scoring. There are seven components of the PSQI (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, daytime dysfunction). The sum of these seven components gives the total PSQI score. Total score ranges from 0-21, and each item gets a score between 0-3 points. A PSQI total score of 5 points and above indicates that the sleep quality is "poor" and a higher score indicates more sleep complaints.
Measured: Last 2 weeks and last 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start31 Aug 2021
- Primary completion12 Feb 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse-Patient RelationsStudies 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
- This study was conducted in a randomized controlled design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Şahin, Harran University
- Investigators
- Seyhan Çıtlık SARITAŞ, PhD, Principal investigator, Turgut ÖZAL University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217497
- Sponsor's protocol ID
- Hemodialysis and Foot Massage
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study was conducted in a randomized controlled manner with experimental and control groups.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage Applied to Patients Undergoing Hemodialysis on Sleep Quality and Fatigue Level:Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06217497
- Acronym / sponsor ID
- Hemodialysis and Foot Massage
- Conditions
- Nurse-Patient Relations
- Keywords
- Foot Massage, Hemodialysis, Nursing, Sleep Quality, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 22 Jan 2024 (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.
Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.
Detailed description
An experimental study design was used to conduct this research on 73 hemodialysis patients treated in a hemodialysis unit. The aim of this study is to investigate how foot massage applied to hemodialysis patients affects sleep quality and fatigue level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted in a randomized controlled design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Foot massageAfter the patients in the experimental group were informed verbally and in writing and consented to participate in the study, the Patient Information Form, the Piper Fatigue Scale (PFS), and the Pittsburgh Sleep Quality Index (PSQI) were applied in the first interview and the initial readings were obtained. The researcher received training on a classical massage from an expert massage therapist before the foot massaging application. Patients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI. |
| Control Group | No intervention | –Patients in the control group were not subjected to any intervention other than routine HD treatment and nursing care. The first readings were obtained by applying the Patient Information Form, PFS and PSQI at the first interview, and the second and third measurement values were obtained by repeating the PFS and PSQI at the end of the second and fourth weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (6 listed)
- Receiving less than 6 months of HD treatment
- Having communication problem
- Suffering from neuropathy
- Having incomplete orientation and any psychiatric problem
- Having a PSQI score below 5
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 massagePatients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI | Other | Experimental Group |
Primary outcome
Piper fatigue scale
Time frame: Last 2 weeks and last 4 weeks
Piper Fatigue Scale (PFS) was developed by Piper et al. The scale consists of a total of 22 items. Each item is rated over 0-10 points through Visual Analogue Scale (VAS) under four subscales related to the patient's subjective perception of fatigue. The behavioural subscale consists of 6 items (2-7), the affective subscale consists of 5 items (8-12), the sensory subscale consists of 5 items (13-17), and the cognitive subscale consists of 6 items [18-23]. Total fatigue score and subscale scores are calculated over 22 items. Items 1, 24, 25, 26 and 27 in the scale are not used in calculating the fatigue score. Total fatigue score is obtained by summing the items and dividing the resultant value by the total number of items, and subscale scores are obtained by summing the scores of all items in that subscale and dividing the resultant value by the number4 of items.
1 secondary outcome
Pittsburgh sleep quality index
Time frame: Last 2 weeks and last 4 weeks
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 22 Jan 2024.
- Individual participant dataSharing planned: Yes. The study was conducted in a randomized controlled manner with experimental and control groups.
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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.
Seyhan Çıtlık SARITAŞ, PhD principal investigator
Turgut ÖZAL University
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 in people with Nurse-Patient Relations, run by Harran 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 7 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 22 Jan 2024. 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?
Piper fatigue scale (time frame: Last 2 weeks and last 4 weeks). 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 22 Jan 2024.