Hemodialysis ComplicationNCT06520631
Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
A study testing Ice packs (cryotherapy) in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
Trial summary
Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Ice packs (cryotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 4 May 2024to 31 Aug 2024
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study includes patients with ages from 30 to 50 years.
- Patients able to report pain adequately.
- Patients with end-stage kidney failure undergoing regular hemodialysis who have been treated for more than 3 months, at least twice per week, with arteriovenous fistula in use for more than 1 month are included in the study.
Who cannot join
- Patients with conditions such as
- advanced age,
- advanced diabetes,
- cardiovascular insufficiency,
- cold allergy,
- Reynaud's phenomenon,
Show all 11Show fewer
- nerve and tissue damage,
- fractures,
- heart failure,
- uncooperative patients,
- cognitive impairment preventing a proper assessment of pain.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo, 11432
Alaa Mohamed El-moatasem, Lecturer, 01006625054 ext. 01205692600, alaamotasem@cu.edu.eg
Nagwa Mohamed Badr, Professor, 01112020504 ext. 01149120620, ngwambadr@yahoo.com
About this study
Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. In HD, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation.
The patients experience considerable pain due to the frequent insertion of AVF catheters.
Read more
Hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process.
Puncture-related pain during arteriovenous fistula (AVF) cannulation in particular is a crucial influential factor in quality of life.
Cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. It can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.
Read the detailed description
Ninety male and female patients with end stage renal disease randomly assigned into three equal groups (n=30) their ages ranged between 30-50:
- Group A (30 patients) receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group B (30 patients) receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group C (30 patients) it is a control group this group not received ice pack.
- Conditions
- Hemodialysis Complication
- Being tested
- Ice packs (cryotherapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice packs (cryotherapy)Other
One group of patients receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
The second group of patients receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy to arteriovenous fistula puncture site | Active comparator | This group of patients receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. Receives: Other: Ice packs (cryotherapy) |
| Cryotherapy to site opposite to arteriovenous fistula puncture site | Active comparator | This group of patients receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. Receives: Other: Ice packs (cryotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS):
Scale to measure the intensity of pain The minimum value is 0 which means no pain and the maximum value is 10 which means the maximum pain
Measured: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions
Secondary outcomes (2)
The Arm Motor Ability Test (AMAT)
The Arm Motor Ability Test (AMAT): is used to assess and quantify upper extremity functional limitation.
Measured: The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Hospital Anxiety and Depression Scale (HADS):
Hospital Anxiety and Depression Scale (HADS):
it is a reliable and valid tool It's questions are clear and easy to understand, and thought the questionnaire items covered all patients problem areas regarding their hospital anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 means maximum impairment and minimum score of 0 means no impairment for anxiety or depression.
Measured: Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start4 May 2024
- Primary completion24 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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 Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fathy Mohamed Elsaid, Cairo University
- Investigators
- Nagwa Mohamed Badr, Professor, Study director, Cairo UniversitySahier Omar El-khashab, Professor, Study director, Cairo university El-kasr el-aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520631
- Sponsor's protocol ID
- P.T.REC/012/005168
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Of Arteriovenous Fistula Puncture-related Pain To Cryotherapy Application In Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT06520631
- Acronym / sponsor ID
- P.T.REC/012/005168
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 May 2024 (actual)
- Primary completion
- 24 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 25 Jul 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.
Kidney disease occurs when kidney reduces its normal function, less than 30% of normal activity is related to a long-term condition. Therefore, people need to participate in a haemodialysis (HD) programme. In HD, blood is filtered by an external machine, done about three times a week and the access is gained through intermittent vascular cannulation.
The patients experience considerable pain due to the frequent insertion of AVF catheters.
Hemodialysis patients experience anxiety before needle insertion due to repeated punctures, and over 90% of patients experience acute pain during the process.
Puncture-related pain during arteriovenous fistula (AVF) cannulation in particular is a crucial influential factor in quality of life.
Cryotherapy is one of the interventions used in several studies to alleviate the arteriovenous fistula puncture-related pain. It can be conduct by using ice packs and the results of the previous studies have also shown its positive effects on the relief of the fistula puncture-related pain in these patients.
Detailed description
Ninety male and female patients with end stage renal disease randomly assigned into three equal groups (n=30) their ages ranged between 30-50:
- Group A (30 patients) receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group B (30 patients) receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis.
- Group C (30 patients) it is a control group this group not received ice pack.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy to arteriovenous fistula puncture site | Active comparator | Other: Ice packs (cryotherapy)This group of patients receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. |
| Cryotherapy to site opposite to arteriovenous fistula puncture site | Active comparator | Other: Ice packs (cryotherapy)This group of patients receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The study includes patients with ages from 30 to 50 years.
- Patients able to report pain adequately.
- Patients with end-stage kidney failure undergoing regular hemodialysis who have been treated for more than 3 months, at least twice per week, with arteriovenous fistula in use for more than 1 month are included in the study.
Key exclusion criteria (11 listed)
- Patients with conditions such as
- advanced age,
- advanced diabetes,
- cardiovascular insufficiency,
- cold allergy,
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 |
|---|---|---|
| Ice packs (cryotherapy)One group of patients receives ice pack applied on the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. The second group of patients receives ice pack applied on contralateral to the site of the cannulation, for 20 sessions (3 sessions per week) it introduced for 5-10 minutes before the beginning of the dialysis. | Other | Cryotherapy to arteriovenous fistula puncture site, Cryotherapy to site opposite to arteriovenous fistula puncture site |
Primary outcome
Visual analogue scale (VAS):
Time frame: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions
Scale to measure the intensity of pain The minimum value is 0 which means no pain and the maximum value is 10 which means the maximum pain
2 secondary outcomes
The Arm Motor Ability Test (AMAT)
Time frame: The Arm Motor Ability Test (AMAT): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Hospital Anxiety and Depression Scale (HADS):
Time frame: Hospital Anxiety and Depression Scale (HADS): it is measured at baseline, and it will be measured again immediately after 20 sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Nagwa Mohamed Badr, Professor study director
Cairo University
Sahier Omar El-khashab, Professor study director
Cairo university El-kasr el-aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice packs (cryotherapy) in people with Hemodialysis Complication, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Fathy El-said, Physical therapist (01205692600 ext. 01149120620, saraghoneem581@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS): (time frame: Visual analogue scale measured at baseline, and it will be measured again immediately after 20 sessions). 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 6 Aug 2024.