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Arteriovenous Fistula Cannulation Pain and Skin Cooling Device

ConditionChronic Kidney Disease on Hemodialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaradeniz Technical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antistress Ball

    Other intervention

    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

  • The Valsalva maneuver

    Other intervention

    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.

  • Skin cooling

    Other intervention

    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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: experimental group (skin cooler device)Experimental treatment 1 intervention
Group B: experimental group (Antistress Ball Group)Experimental treatment 1 intervention
Group C: experimental group (Valsalva Maneuver Group)Experimental treatment 1 intervention
Group D: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
4 week
2

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.

Time frame
4 week
3

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

Time frame
4 week
4

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.

Time frame
4 week

Secondary outcomes

1

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.

Time frame
8 week
2

Experimental (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

Time frame
8 week
3

Experimental group (Valsalva Maneuver Group) Visual Analog 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 of 0 to 10 in patients means that there is no pain, a pain rating of 1 to 3 means mild pain, 4 to 6 moderate pain, and a pain rating of 7 or higher means severe pain.

Time frame
8 week
4

Experimental (The valsalva maneuver 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

Time frame
8 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karadeniz Technical University

Lead sponsor

Gümüşhane Universıty

Sponsor institution

Gümüşhane Universıty

Collaborator

Source ClinicalTrials.gov

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