CClinicalTrials.gg
Status unknownNCT05480397Updated Jul 29, 2022

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION VERSUS DISTRACTIVE TECHNIQUES ON ARTERIOVENOUS FISTULA PUNCTURE PAIN IN HEMODIALYSIS PATIENTS

An interventional study of TENS, Distractive techniques, cryotherapy in TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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 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.
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:

    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.

02

Conditions studied

  • TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis
03

In context

Arteriovenous Fistula

267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's planned enrollment of 45 is below the median of 68 across 177 interventional studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    • Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).

    Other: TENS, Distractive techniques, cryotherapy

  • Experimental
    •Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy)

    Other: TENS, Distractive techniques, cryotherapy

  • Experimental
    • Group (3) will receive (cryotherapy and conventional physical therapy program).

    Other: TENS, Distractive techniques, cryotherapy

Interventions

  • OtherTENS, 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 )

06

What researchers measure

Primary outcomes

  1. The KDQOL-36, Numerical Rating Scale for pain measurement

    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 \[25\].

    Time frame: one hour for each participant

07

Study locations

1 of 1 sites recruiting
  • Hemodialysis unit, General Ashmoon Hospital
    Ashmoon, Menofia, Menofia, Egypt
    • Gamal Abdlmohsen Abdelhakim, physical therapist · Contact · 200102123253
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05480397
Lead sponsor
Cairo University
Responsible party
Gamal Abdelmohsen Abdelhakim Hassan (physical therapist, Cairo University) — Principal investigator
First posted
Jul 29, 2022
Start date
Jun 15, 2022
Primary completion
Sep 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Jul 29, 2022

Study contacts

Gamal Abdlmohsen Abdelhakim, physical therapist
Contact
2001092123253
Amaal Hassan Ibrahim, professor of physical therapy
Contact
aebrahim123@hotmail.com
2001200861702

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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