Antistress Ball Applied to Hemodialysis Patients, Valsalva Maneuver and Pain Due to Arteriovenous Fistula Cannulation of Skin Cooling Device and the Effect of Fear of Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Experimental group (skin cooling) The Pain Catastrophization Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Experimental group (skin cooling) The Pain Catastrophization Scale
时间窗: 4 week
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.
Experimental (Skin cooling) Pain (Visual Analogue Pain Scale)
时间窗: 4 week
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.
Experimental (The valsalva maneuver group)The pain catastrophizing scale
时间窗: 4 week
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
Experimental (The valsalva maneuver group) Pain (Visual Analogue Pain Scale)
时间窗: 4 week
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.
Experimental group (Antistress ball group) The Pain Catastrophization Scale
时间窗: 4 week
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.
Experimental (Antistress ball group) Pain (Visual Analogue Pain Scale)
时间窗: 4 week
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.
Control group The Pain Catastrophization Scale
时间窗: 4 week
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.
Control Group Pain (Visual Analogue Pain Scale)
时间窗: 4 week
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.
次要结局
- 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)
- Experimental (Antistress ball group) The Pain Catastrophization Scale(8 week)
- Control Group Pain (Visual Analogue Pain Scale)(8 week)
- Control group The Pain Catastrophization Scale(8 week)
研究者
AYNUR CİN
Principal Investigator
Gümüşhane Universıty