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.
Patients with chronic renal failure who are being treated with hemodialysis experience pain during invasive intervention with arteriovenous fistula. This condition negatively affects hemodialysis patients and leads to a decrease in their quality of life. In order to reduce the pain and fear experienced during arteriovenous fistula intervention, it is recommended to use pharmacological methods as well as nonpharmacological methods. Antistress ball, which is one of the nonpharmacological methods, reduces pain during arteriovenous fistula intervention by causing distraction in hemodialysis patients, but its effect on fear of pain is not yet known. Of the other nonpharmacological methods, the valsalva maneuver reduces pain during vascular intervention, but the pain and fear of pain during arteriovenous fistula intervention have not yet been investigated. In the same way, the effects of skin cooling device on pain and fear of pain during arteriovenous fistula intervention are unknown. The aim of this randomized controlled trial is to; 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. This study will be conducted in an experimental type and 60 patients receiving hemodialysis treatment at X State Hospital hemodialysis unit will form the sample of the study. All patients in the experimental group will be given nonpharmacological applications (antistress ball, valsalva maneuver and skin cooling application) for 8 weeks, three times a week. The control group will not be given any intervention and will receive routine treatment. The 'Pain Catastrophization Scale' will be applied to the experimental and control groups before, in the middle and after the research. The 'Visual Analog Pain Scale\" will be used to determine the pain severity of hemodialysis patients before and after arteriovenous fistula intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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 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 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
Kelkit State Hospital
Kelkit, Gümüşhane Province, Turkey (Türkiye)
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
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
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 week
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
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
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
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.
Time frame: 8 week
Experimental (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
Time frame: 8 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.
Time frame: 8 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
Time frame: 8 week