Arteriovenous Fistula Cannulation Pain and Skin Cooling Device

NCT06588114 | Not Yet Recruiting DMC

• 1 other identifier: E-95674917-108.99-248196
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of the antistress ball, valsalva maneuver and skin cooling device, which are one of the nonpharmacological methods applied to hemodialysis patients, on the level of pain and fear of pain due to arteriovenous fistula cannulation.

Conditions

Chronic Kidney Disease on Hemodialysis

Keywords

Hemodialysis; Arteriovenous fistula; Valsalva; Antistress ball

Outcome Measures

Primary Outcomes (8)

• Experimental group (skin cooling) The Pain Catastrophization Scale

  This scale, developed by Sullivan et al. (1995), serves to measure the exaggerated negative mental reaction of individuals to an existing or predicted painful experience; to what extent they catastrophize the pain in the form of self-information . The reliability and validity of the Turkish version of the scale, which was shown by Uğurlu and others (2017), consists of 13 items. Each item is scored as none at all=0, mild degree=1, moderate degree=2, major degree=3 and always=4. A high total score indicates that the person has a high degree of catastrophizing pain.

  4 week

• Experimental (Skin cooling) Pain (Visual Analogue Pain Scale)

  The visual analog pain scale will be used to measure pain in hemodialysis patients. The scale consists of a horizontal line 10 cm tall. A VAS score of 0, consisting of numerical values sorted on a horizontal line, indicates that there is no pain at all, while a score of 10 indicates the most severe pain. A pain rating of 0 on a scale with a rating between 0 and 10 in patients means that there is no pain, a pain rating of 1 to 3 Decrees mild pain, 4 to 6 moderate pain and a pain rating of 7 or higher Decrees severe pain.

  4 week

• Experimental (The valsalva maneuver group)The pain catastrophizing scale

  This scale, developed by Sullivan et al. (1995), serves to measure the exaggerated negative mental reaction of individuals to an existing or predicted painful experience; to what extent they catastrophize the pain in the form of self-information.The reliability and validity of the Turkish version of the scale, which was shown by Uğurlu and others (2017), consists of 13 items. Each item is scored as none at all=0, mild degree=1, moderate degree=2, major degree=3 and always=4. A high total score indicates that the person has a high degree of catastrophizing pain

  4 week

• Experimental (The valsalva maneuver group) Pain (Visual Analogue Pain Scale)

  The visual analog pain scale will be used to measure pain in hemodialysis patients. The scale consists of a horizontal line 10 cm tall. A VAS score of 0, consisting of numerical values sorted on a horizontal line, indicates that there is no pain at all, while a score of 10 indicates the most severe pain. A pain rating of 0 on a scale with a rating between 0 and 10 in patients means that there is no pain, a pain rating of 1 to 3 Decrees mild pain, 4 to 6 moderate pain and a pain rating of 7 or higher Decrees severe pain.

  4 week

• Experimental group (Antistress ball group) The Pain Catastrophization Scale

  This scale, developed by Sullivan et al. (1995), serves to measure the exaggerated negative mental reaction of individuals to an existing or predicted painful experience; to what extent they catastrophize the pain in the form of self-information . The reliability and validity of the Turkish version of the scale, which was shown by Uğurlu and others (2017), consists of 13 items. Each item is scored as none at all=0, mild degree=1, moderate degree=2, major degree=3 and always=4. A high total score indicates that the person has a high degree of catastrophizing pain.

  4 week

• Experimental (Antistress ball group) Pain (Visual Analogue Pain Scale)

  The visual analog pain scale will be used to measure pain in hemodialysis patients. The scale consists of a horizontal line 10 cm tall. A VAS score of 0, consisting of numerical values sorted on a horizontal line, indicates that there is no pain at all, while a score of 10 indicates the most severe pain. A pain rating of 0 on a scale with a rating between 0 and 10 in patients means that there is no pain, a pain rating of 1 to 3 Decrees mild pain, 4 to 6 moderate pain and a pain rating of 7 or higher Decrees severe pain.

  4 week

• Control group The Pain Catastrophization Scale

  This scale, developed by Sullivan et al. (1995), serves to measure the exaggerated negative mental reaction of individuals to an existing or predicted painful experience; to what extent they catastrophize the pain in the form of self-information . The reliability and validity of the Turkish version of the scale, which was shown by Uğurlu and others (2017), consists of 13 items. Each item is scored as none at all=0, mild degree=1, moderate degree=2, major degree=3 and always=4. A high total score indicates that the person has a high degree of catastrophizing pain.

  4 week

• Control Group Pain (Visual Analogue Pain Scale)

  The visual analog pain scale will be used to measure pain in hemodialysis patients. The scale consists of a horizontal line 10 cm tall. A VAS score of 0, consisting of numerical values sorted on a horizontal line, indicates that there is no pain at all, while a score of 10 indicates the most severe pain. A pain rating of 0 on a scale with a rating between 0 and 10 in patients means that there is no pain, a pain rating of 1 to 3 Decrees mild pain, 4 to 6 moderate pain and a pain rating of 7 or higher Decrees severe pain.

  4 week

Secondary Outcomes (8)

• Experimental(Skin cooling) Pain (Visual Analogue Pain Scale)

  8 week

• Experimental (Skin cooling) The Pain Catastrophization Scale

  8 week

• Experimental group (Valsalva Maneuver Group) Visual Analog Pain Scale

  8 week

• Experimental (The valsalva maneuver group) The Pain Catastrophization Scale

  8 week

• Experimental(Antistress ball group) Pain (Visual Analogue Pain Scale)

  8 week

Study Arms (4)

experimental group (skin cooler device)

EXPERIMENTAL

Hemodialysis patients in this group will be provided with skin temperature reduction by the researcher with a skin cooling device for 10 minutes before the arteriovenous fistula attempt is made.

Other: Skin cooling

experimental group (Antistress Ball Group)

EXPERIMENTAL

Hemodialysis patients in this group will be asked to look away by giving an antistress ball to the non-arteriovenous fistula hand and squeezing and then loosening the ball during the arteriovenous fistula intervention.

Other: Antistress Ball

experimental group (Valsalva Maneuver Group)

EXPERIMENTAL

The Valsalva maneuver is a breathing method that can slow down a heart with a very fast pulse rate. In this maneuver, the individual breathes strongly through his mouth while his nose is tightly closed, and while holding his breath, a strong tension occurs. This maneuver allows the heart to react and return to a normal rhythm. Hemodialysis patients in this group will perform the valsalva maneuver taught to them by the researcher during arteriovenous intervention.

Other: The Valsalva maneuver

control group

NO INTERVENTION

Hemodialysis patients aged 18 years and older who have arteriovenous fistula and have been on hemodialysis for more than three months will be included in the control group. No intervention will be made to the control group. Patients in this group will receive routine check-ups and hemodialysis treatments.

Interventions

Antistress Ball OTHER

Hemodialysis patients will be asked to look away by giving an antistress ball to the non-arteriovenous fistula hand and squeezing and then loosening the ball during the arteriovenous fistula intervention

experimental group (Antistress Ball Group)

The Valsalva maneuver OTHER

The Valsalva maneuver is a breathing method that can slow down a heart with a very fast pulse rate. In this maneuver, the individual breathes strongly through his mouth while his nose is tightly closed, and while holding his breath, a strong tension occurs. This maneuver allows the heart to react and return to a normal rhythm.

experimental group (Valsalva Maneuver Group)

Skin cooling OTHER

Hemodialysis patients will be provided with lowering of skin temperature with a skin cooling device by the researcher for 10 minutes before arteriovenous fistula intervention is made to hemodialysis patients

experimental group (skin cooler device)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 18 years of age or older
• Volunteering to participate in the study
• Being a hemodialysis patient and being on hemodialysis for more than three months
• Having an arteriovenous fistula that has been used for more than a month
• To be hemodialyzed three times a week
• To be literate
• Absence of communication barrier
• Not having any psychiatric diagnosis
• Not having cognitive impairment

You may not qualify if:

• being under the age of 18
• It takes less than a month for the arteriovenous fistula to be newly opened
• Having a different type of vascular interference from arteriovenous fistula
• Having phlebitis, scar tissue, dermatitis, an incision or infection at the site of arteriovenous interference
• Hemodialysis of the patient more or less than three times a week
• Having any disease that may affect the perception of pain
• Illiteracy
• Having a psychiatric diagnosis
• Having any discomfort in the hand and arm that allows squeezing the antistress ball
• There is a communication barrier
• Having a cognitive impairment

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Gümüşhane Universıty: collaborator

Study Sites (1)

Kelkit State Hospital

Kelkit, Gümüşhane Province, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• AYNUR CIN, DR

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYNUR CIN, DR

CONTACT

4562331053; aynur.86.92@gmail.com

ESRA TANIŞ, STUDENT

CONTACT

4562331053; tanisesra4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 01.10.2024-31.12.2024
• Access Criteria: It can be received by e-mail with the permission of the researcher.

Locations

TU (1)