TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, HemodialysisNCT05480397
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
A study testing TENS, Distractive techniques, cryotherapy in people with TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem: This study will be conducted to answer the following question: Is there a difference in the efficacy of TENS and distractive techniques when combined with cryotherapy in managing pain due to arteriovenous fistula puncture and improving quality of life in hemodialysis patients ? Null… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis
- What is being tested?
- TENS, Distractive techniques, cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to Oct 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-Inclusion criteria:
- Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
- At least one year passed from the installation of AVF and hemodialysis.
- Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
- Having no traces of skin abnormalities or analgesia in vessels access point.
Who cannot join
- 2-Exclusion Criteria:
- The following were considered exclusion criteria:
- Unwillingness to continue with the study.
- Unsuccessful AVF cannulation at the first try.
- Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
- Presence of infection and obstruction of fistula based on the nurse's inspection.
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- The presence of auditory and visual disturbances.
- history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis.
- Having traces of severe pain in other parts.
- Having pacemakers
Trial locations and contacts
1 site in 1 country.
Gamal Abdlmohsen Abdelhakim, physical therapist contact
Egypt1 site, 1 recruiting
- Recruiting
Hemodialysis unit, General Ashmoon Hospital
Ashmoon, Menofia, Menofia
Gamal Abdlmohsen Abdelhakim, physical therapist, 200102123253
About this study
Statement of the problem:
This study will be conducted to answer the following question:
Read more
Is there a difference in the efficacy of TENS and distractive techniques when combined with cryotherapy in managing pain due to arteriovenous fistula puncture and improving quality of life in hemodialysis patients ?
Null Hypotheses:
- TENS has no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- Distractive techniques have no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- There is no statistically significant difference between TENS and distractive techniques in managing pain and improving quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
Read the detailed description
Subjects' Selection:
The patients will be randomly assigned to 3 groups;
- Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).
- Group (2) will receive (distractive techniques , cryotherapy and conventional physical therapy program).
- Group (3) will receive (cryotherapy and conventional physical therapy program). Patients will be assessed for quality of life before and after treatment and will receive 3 sessions per week consisted of TENS, distractive techniques , Cryotherapy and conventional physical therapy program during AVF Puncture during dialysis for 4 weeks. 1-Inclusion criteria:
- Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
- At least one year passed from the installation of AVF and hemodialysis.
- Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
- Having no traces of skin abnormalities or analgesia in vessels access point. 2-Exclusion Criteria:
The following were considered exclusion criteria:
- Unwillingness to continue with the study.
- Unsuccessful AVF cannulation at the first try.
- Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
- Presence of infection and obstruction of fistula based on the nurse's inspection.
- The presence of auditory and visual disturbances.
- history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis.
- Having traces of severe pain in other parts.
- Having pacemakers. The patients will be randomly assigned to 3 groups; Group(1) will receive TENS , cryotherapy and conventional physical therapy program, Group(2) will receive distractive techniques , cryotherapy and conventional physical therapy program and Group(3) will receive cryotherapy and conventional physical therapy program.
All groups will be assessed for quality of life using Kidney Disease Quality of Life Short Form Scale (KDQOL-SF) before and after treatment.
- Being tested
- TENS, Distractive techniques, cryotherapy
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS, Distractive techniques, cryotherapyOther
Group (1): Will receive (TENS , cryotherapy and conventional physical therapy ) Massage with ice was done by the researcher over the AVF puncture site . After that, the TENS electrodes will be applied by the researcher 6 centimeters apart closely up and down the skin area for insertion of the needle.
- Group (2): Will receive (Distraction techniques ,cryotherapy and conventional physical therapy ) Initially five minutes before starting hemodialysis, Distraction techniques will be applied. Natural and eye-catching images were broadcasted through a video display device on a laptop monitor in a manner that was easy for the older patient to watch while they were lying on the bed. Massage with ice was done by the researcher over the AVF puncture site
- Group (3): Will receive (cryotherapy and conventional physical therapy )
| Study group | Role | What they receive |
|---|---|---|
| • Group (1) will receive (TENS , cryotherapy and conventional physical therapy program). | Experimental | Not described Receives: Other: TENS, Distractive techniques, cryotherapy |
| •Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy) | Experimental | Not described Receives: Other: TENS, Distractive techniques, cryotherapy |
| • Group (3) will receive (cryotherapy and conventional physical therapy program). | Experimental | Not described Receives: Other: TENS, Distractive techniques, cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The KDQOL-36, Numerical Rating Scale for pain measurement
- Numerical Rating Scale of Pain Severity is numbered between 0 and 10 indicating positive and negative pain statements, respectively. Accordingly, the rating of this scale was 0 (lack of pain), 1-3 (low pain), 4-6 (moderate pain), 7-9 (severe pain), and 10 (very severe pain). The Cronbach's alpha coefficient for this tool was reported as 0.95 and its reliability score using the intra-class correlation coefficient was 0.92 (Mirtajadini et al., 2016).
- The KDQOL-36:
It is a 36-item health-related quality of life instrument adapted from the original 134-item KDQOL, an instrument principally developed to measure quality of life of dialysis patients [25].
Measured: one hour for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Jun 2022
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, HemodialysisStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Abdelmohsen Abdelhakim Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480397
- Sponsor's protocol ID
- P.T.REC/012/003723
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
- ClinicalTrials.gov ID
- NCT05480397
- Acronym / sponsor ID
- P.T.REC/012/003723
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Jul 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.
Statement of the problem:
This study will be conducted to answer the following question:
Is there a difference in the efficacy of TENS and distractive techniques when combined with cryotherapy in managing pain due to arteriovenous fistula puncture and improving quality of life in hemodialysis patients ?
Null Hypotheses:
- TENS has no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- Distractive techniques have no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
- There is no statistically significant difference between TENS and distractive techniques in managing pain and improving quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
Detailed description
Subjects' Selection:
The patients will be randomly assigned to 3 groups;
- Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).
- Group (2) will receive (distractive techniques , cryotherapy and conventional physical therapy program).
- Group (3) will receive (cryotherapy and conventional physical therapy program). Patients will be assessed for quality of life before and after treatment and will receive 3 sessions per week consisted of TENS, distractive techniques , Cryotherapy and conventional physical therapy program during AVF Puncture during dialysis for 4 weeks. 1-Inclusion criteria:
- Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
- At least one year passed from the installation of AVF and hemodialysis.
- Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
- Having no traces of skin abnormalities or analgesia in vessels access point. 2-Exclusion Criteria:
The following were considered exclusion criteria:
- Unwillingness to continue with the study.
- Unsuccessful AVF cannulation at the first try.
- Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
- Presence of infection and obstruction of fistula based on the nurse's inspection.
- The presence of auditory and visual disturbances.
- history of verbal disturbances; no addiction or drug dependence to pain medications; no history of mental health diseases; being conscious, having not taken painkillers, narcotics or sedatives at least six hours before hemodialysis.
- Having traces of severe pain in other parts.
- Having pacemakers. The patients will be randomly assigned to 3 groups; Group(1) will receive TENS , cryotherapy and conventional physical therapy program, Group(2) will receive distractive techniques , cryotherapy and conventional physical therapy program and Group(3) will receive cryotherapy and conventional physical therapy program.
All groups will be assessed for quality of life using Kidney Disease Quality of Life Short Form Scale (KDQOL-SF) before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| • Group (1) will receive (TENS , cryotherapy and conventional physical therapy program). | Experimental | Other: TENS, Distractive techniques, cryotherapy |
| •Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy) | Experimental | Other: TENS, Distractive techniques, cryotherapy |
| • Group (3) will receive (cryotherapy and conventional physical therapy program). | Experimental | Other: TENS, Distractive techniques, cryotherapy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1-Inclusion criteria:
Key exclusion criteria (10 listed)
- 2-Exclusion Criteria:
- Unwillingness to continue with the study.
- Unsuccessful AVF cannulation at the first try.
- Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
- Presence of infection and obstruction of fistula based on the nurse's inspection.
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 |
|---|---|---|
| TENS, Distractive techniques, cryotherapyGroup (1): Will receive (TENS , cryotherapy and conventional physical therapy ) Massage with ice was done by the researcher over the AVF puncture site . After that, the TENS electrodes will be applied by the researcher 6 centimeters apart closely up and down the skin area for insertion of the needle. * Group (2): Will receive (Distraction techniques ,cryotherapy and conventional physical therapy ) Initially five minutes before starting hemodialysis, Distraction techniques will be applied. Natural and eye-catching images were broadcasted through a video display device on a laptop monitor in a manner that was easy for the older patient to watch while they were lying on the bed. Massage with ice was done by the researcher over the AVF puncture site * Group (3): Will receive (cryotherapy and conventional physical therapy ) | Other | • Group (1) will receive (TENS , cryotherapy and conventional physical therapy program)., • Group (3) will receive (cryotherapy and conventional physical therapy program)., •Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy) |
Primary outcome
The KDQOL-36, Numerical Rating Scale for pain measurement
Time frame: one hour for each participant
1. Numerical Rating Scale of Pain Severity is numbered between 0 and 10 indicating positive and negative pain statements, respectively. Accordingly, the rating of this scale was 0 (lack of pain), 1-3 (low pain), 4-6 (moderate pain), 7-9 (severe pain), and 10 (very severe pain). The Cronbach's alpha coefficient for this tool was reported as 0.95 and its reliability score using the intra-class correlation coefficient was 0.92 (Mirtajadini et al., 2016). 2. The KDQOL-36: It is a 36-item health-related quality of life instrument adapted from the original 134-item KDQOL, an instrument principally developed to measure quality of life of dialysis patients [25].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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.
Gamal Abdlmohsen Abdelhakim, physical therapist contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS, Distractive techniques, cryotherapy in people with TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis, 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 5 inclusion and 10 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 29 Jul 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 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 Gamal Abdlmohsen Abdelhakim, physical therapist (2001092123253), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The KDQOL-36, Numerical Rating Scale for pain measurement (time frame: one hour for each participant). 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 29 Jul 2022.