Hemodialysis ComplicationNCT04681521
Hot and Cold Compress in Hemodialysis
A study testing Hot and Cold compress, nursing interventions in people with Hemodialysis Complication and Muscle Spasm, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients. Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication, Muscle Spasm, Fatigue
- What is being tested?
- Hot and Cold compress, nursing interventions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 20 Nov 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between the ages of 18-65,
- receiving HD treatment for at least six months,
- three days a week with four-hour sessions
- with blood pressure 120/80 mmHg and higher at the beginning of the HD session,
- did not develop intradialytic hypotension in the first two hours of HD,
- hemoglobin value above 8.0 mg/dL,
- having a stable dry weight for the previous month (less than 2 kg change).
Who cannot join
- receiving intravenous electrolyte replacement during HD session,
- having a condition that prevented hot or cold administration such as diabetic neuropathy, burns, open wounds, and amputation in the lower extremities,
- with an oncological diagnosis or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, fibromyalgia, etc.),
- refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, None Selected, 06100
About this study
Official title: The Effects of Hot and Cold Compress on Muscle Cramps, Fatigue And Comfort in Hemodialysis Patients: A Placebo Controlled Randomized Trial
Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.
Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Among the nursing interventions stated for the management of these complications in the literature, hot and cold therapy are remarkable. To the best of our knowledge, the present study is the first research up to date that examined and compared the effects of hot and cold compress administrations on abovementioned complications in HD.
Read more
Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers between February and October 2020.
Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two intervention groups and placebo group. For patients of each group, the implementation of the study continued for four weeks, 12 HD sessions.
Read the detailed description
Hemodialysis (HD) is a common renal replacement therapy used in the treatment of End-Stage Renal Disease (ESRD) worldwide. Although HD is a life-saving treatment for people with ESRD, it causes some acute and chronic complications. Muscle cramps and fatigue are two of the most common complications in HD, and these also cause reducing comfort. Management of complications in HD patients and ensuring an optimal comfort level are pivotal for nurses. According to the literature, recommended nursing practices for the management of cramps in HD patients include hot and cold therapy methods. Besides, preventing cramps can improve comfort by reducing fatigue. Therefore, this study aimed to examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.
- Conditions
- Hemodialysis Complication, Muscle Spasm, Fatigue
- Being tested
- Hot and Cold compress, nursing interventions
- Keywords
- hemodialysis, muscle cramp, fatigue, comfort, nursing care, complementary therapies
- Medical subject headings
- Spasm, Fatigue, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot and Cold compress, nursing interventionsOther
using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients
| Study group | Role | What they receive |
|---|---|---|
| HOT THERAPY:GROUP A | Experimental | Hot Compress Group Receives: Other: Hot and Cold compress, nursing interventions |
| COLD THERAPY:GROUP B | Experimental | Cold Compress Group Receives: Other: Hot and Cold compress, nursing interventions |
| PLACEBO: GROUP C | Placebo comparator | Inoperative compress Group Receives: Other: Hot and Cold compress, nursing interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle cramps
Throughout the hemodialysis treatment, the patients were monitored in terms of cramp development and cramp development was recorded in the follow-up chart (CEFC). This chart was created by the researcher through literature review. Each involuntary contraction session in the legs of the patients was evaluated as an episode.
Measured: 4 weeks
Secondary outcomes (1)
Fatigue
At the end of each hemodialysis session, the fatigue level of all participants was measured and recorded using the Piper Fatigue Scale.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Feb 2020
- Primary completion30 Oct 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo controlled randomized trial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah Kesik, Hacettepe University
- Investigators
- Leyla Özdemir, Prof. Dr., Study director, Hacettepe UniversityTolga Yıldırım, Assos. Prof., Study director, Hacettepe UniversityCebrail Cebrailov, M.D., Study chair, Hacettepe UniversityGülseren Çeliksöz, M.D., Study chair, Betamar Dialysis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681521
- Sponsor's protocol ID
- KA-19143
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the informed consent form presented to the patients at the beginning of the study, it was clearly stated that individual data would be kept confidential. only data based on study results will be shared as scientific content.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hot and Cold Compress on Muscle Cramps, Fatigue And Comfort in Hemodialysis Patients: A Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT04681521
- Acronym / sponsor ID
- KA-19143
- Conditions
- Hemodialysis Complication, Muscle Spasm, Fatigue
- Keywords
- hemodialysis, muscle cramp, fatigue, comfort, nursing care, complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 23 Dec 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.
Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.
Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Among the nursing interventions stated for the management of these complications in the literature, hot and cold therapy are remarkable. To the best of our knowledge, the present study is the first research up to date that examined and compared the effects of hot and cold compress administrations on abovementioned complications in HD.
Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers between February and October 2020.
Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two intervention groups and placebo group. For patients of each group, the implementation of the study continued for four weeks, 12 HD sessions.
Detailed description
Hemodialysis (HD) is a common renal replacement therapy used in the treatment of End-Stage Renal Disease (ESRD) worldwide. Although HD is a life-saving treatment for people with ESRD, it causes some acute and chronic complications. Muscle cramps and fatigue are two of the most common complications in HD, and these also cause reducing comfort. Management of complications in HD patients and ensuring an optimal comfort level are pivotal for nurses. According to the literature, recommended nursing practices for the management of cramps in HD patients include hot and cold therapy methods. Besides, preventing cramps can improve comfort by reducing fatigue. Therefore, this study aimed to examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- placebo controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| HOT THERAPY:GROUP A | Experimental | Other: Hot and Cold compress, nursing interventionsHot Compress Group |
| COLD THERAPY:GROUP B | Experimental | Other: Hot and Cold compress, nursing interventionsCold Compress Group |
| PLACEBO: GROUP C | Placebo comparator | Other: Hot and Cold compress, nursing interventionsInoperative compress Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- between the ages of 18-65,
- receiving HD treatment for at least six months,
- three days a week with four-hour sessions
- with blood pressure 120/80 mmHg and higher at the beginning of the HD session,
- did not develop intradialytic hypotension in the first two hours of HD,
Key exclusion criteria (4 listed)
- receiving intravenous electrolyte replacement during HD session,
- having a condition that prevented hot or cold administration such as diabetic neuropathy, burns, open wounds, and amputation in the lower extremities,
- with an oncological diagnosis or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, fibromyalgia, etc.),
- refused to participate in the study
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 |
|---|---|---|
| Hot and Cold compress, nursing interventionsusing thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients | Other | COLD THERAPY:GROUP B, HOT THERAPY:GROUP A, PLACEBO: GROUP C |
Primary outcome
muscle cramps
Time frame: 4 weeks
Throughout the hemodialysis treatment, the patients were monitored in terms of cramp development and cramp development was recorded in the follow-up chart (CEFC). This chart was created by the researcher through literature review. Each involuntary contraction session in the legs of the patients was evaluated as an episode.
1 secondary outcome
Fatigue
Time frame: 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 23 Dec 2020.
- Individual participant dataSharing planned: No. In the informed consent form presented to the patients at the beginning of the study, it was clearly stated that individual data would be kept confidential. only data based on study results will be shared as scientific content.
Related trials for Hemodialysis Complication
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
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 Özdemir, Prof. Dr. study director
Hacettepe University
Tolga Yıldırım, Assos. Prof. study director
Hacettepe University
Cebrail Cebrailov, M.D. study chair
Hacettepe 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 Hot and Cold compress, nursing interventions in people with Hemodialysis Complication and Muscle Spasm, run by Hacettepe 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 4 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 23 Dec 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. Some participants in this study may receive a placebo. 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?
muscle cramps (time frame: 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 23 Dec 2020.