TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS
NCT ID: NCT05480397
Last Updated: 2022-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2022-06-15
2022-10-31
Brief Summary
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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:
1. TENS has no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
2. Distractive techniques have no statistically significant effect on pain management and quality of life in hemodialysis patients undergoing arteriovenous fistula puncture.
3. 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
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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:
1. Patient age will range from 20 - 60 years who have chronic renal failure from males and females.
2. At least one year passed from the installation of AVF and hemodialysis.
3. Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
4. Having no traces of skin abnormalities or analgesia in vessels access point.
2-Exclusion Criteria:
The following were considered exclusion criteria:
1. Unwillingness to continue with the study.
2. Unsuccessful AVF cannulation at the first try.
3. Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
4. Presence of infection and obstruction of fistula based on the nurse's inspection.
5. The presence of auditory and visual disturbances.
6. 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.
7. Having traces of severe pain in other parts.
8. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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• Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).
TENS, Distractive techniques, cryotherapy
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 )
•Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy)
TENS, Distractive techniques, cryotherapy
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 )
• Group (3) will receive (cryotherapy and conventional physical therapy program).
TENS, Distractive techniques, cryotherapy
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 )
Interventions
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TENS, Distractive techniques, cryotherapy
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 )
Eligibility Criteria
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Inclusion Criteria
2. At least one year passed from the installation of AVF and hemodialysis.
3. Patients are undergoing hemodialysis three sessions per week and each session lasting for 4 hours.
4. Having no traces of skin abnormalities or analgesia in vessels access point.
Exclusion Criteria
2. Unsuccessful AVF cannulation at the first try.
3. Patients having radiation injuries, peripheral vascular diseases, Raynauld's disease, connective tissue disorders, diabetic neuropathy, unconsciousness or disorientation.
4. Presence of infection and obstruction of fistula based on the nurse's inspection.
5. The presence of auditory and visual disturbances.
6. 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.
7. Having traces of severe pain in other parts.
8. Having pacemakers
20 Years
60 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Gamal Abdelmohsen Abdelhakim Hassan
physical therapist
Locations
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Hemodialysis unit, General Ashmoon Hospital
Ashmoon, Menofia, Menofia, Egypt
Countries
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Central Contacts
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Gamal Abdlmohsen Abdelhakim, physical therapist
Role: CONTACT
Phone: 2001092123253
Amaal Hassan Ibrahim, professor of physical therapy
Role: CONTACT
Phone: 2001200861702
Email: [email protected]
Facility Contacts
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Gamal Abdlmohsen Abdelhakim, physical therapist
Role: primary
Other Identifiers
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P.T.REC/012/003723
Identifier Type: -
Identifier Source: org_study_id