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

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.

Study Overview

• Status: Recruiting
• Conditions: TENS, Distractive Techniques, Arteriovenous Fistula, Puncture Pain, Hemodialysis
• Intervention / Treatment: Other: TENS, Distractive techniques, cryotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gamal Abdlmohsen Abdelhakim, physical therapist; Phone Number: 2001092123253
• Study Contact Backup: Name: Amaal Hassan Ibrahim, professor of physical therapy; Phone Number: 2001200861702; Email: aebrahim123@hotmail.com

Study Locations

• Egypt
  • Menofia
    • Ashmoon, Menofia, Menofia, Egypt
      • Recruiting
      • Hemodialysis unit, General Ashmoon Hospital
      • Contact: Gamal Abdlmohsen Abdelhakim, physical therapist; Phone Number: 200102123253

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: • Group (1) will receive (TENS , cryotherapy and conventional physical therapy program).	Other: 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 )
EXPERIMENTAL: •Group (2) receive (distractive techniques , cryotherapy and conventional physical therapy)	Other: 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 )
EXPERIMENTAL: • Group (3) will receive (cryotherapy and conventional physical therapy program).	Other: 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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	one hour for each participant

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (ACTUAL): July 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: P.T.REC/012/003723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No