Chronic Kidney Disease on HemodialysisHD patientsNCT06588114
Arteriovenous Fistula Cannulation Pain and Skin Cooling Device
A study testing Antistress Ball, The Valsalva maneuver and Skin cooling in people with Chronic Kidney Disease on Hemodialysis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis
- What is being tested?
- Antistress Ball, The Valsalva maneuver and Skin cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Absence of communication barrier
- Not having any psychiatric diagnosis
- Not having cognitive impairment
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kelkit State Hospital
Kelkit, Gümüşhane Province, 29600
FEYZA DALTABAN, DR, 4563171450, gumushanedhs1@saglik.gov.tr
AYNUR CIN, DR
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Being tested
- Antistress Ball, The Valsalva maneuver, Skin cooling
- Keywords
- Hemodialysis, Arteriovenous fistula, Valsalva, Antistress ball
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antistress BallOther
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 maneuverOther
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 coolingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 week
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease on HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Gümüşhane Universıty
- Responsible party
- Principal investigator, AYNUR CİN, Gümüşhane Universıty
- Investigators
- AYNUR CIN, DR, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588114
- Sponsor's protocol ID
- E-95674917-108.99-248196
- Acronym
- HD patients
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06588114
- Acronym / sponsor ID
- HD patients / E-95674917-108.99-248196
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Keywords
- Hemodialysis, Arteriovenous fistula, Valsalva, Antistress ball
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- Gümüşhane Universıty
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experimental group (skin cooler device) | Experimental | Other: Skin coolingHemodialysis 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. |
| experimental group (Antistress Ball Group) | Experimental | Other: Antistress BallHemodialysis 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. |
| experimental group (Valsalva Maneuver Group) | Experimental | Other: The Valsalva maneuverThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antistress BallHemodialysis 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 | Other | experimental group (Antistress Ball Group) |
| The Valsalva maneuverThe 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. | Other | experimental group (Valsalva Maneuver Group) |
| Skin coolingHemodialysis 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 | Other | experimental group (skin cooler device) |
Primary outcome
Experimental group (skin cooling) The Pain Catastrophization Scale
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Experimental(Skin cooling) Pain (Visual Analogue Pain Scale)
Time frame: 8 week
Experimental (Skin cooling) The Pain Catastrophization Scale
Time frame: 8 week
Experimental group (Valsalva Maneuver Group) Visual Analog Pain Scale
Time frame: 8 week
Experimental (The valsalva maneuver group) The Pain Catastrophization Scale
Time frame: 8 week
Experimental(Antistress ball group) Pain (Visual Analogue Pain Scale)
Time frame: 8 week
Experimental (Antistress ball group) The Pain Catastrophization Scale
Time frame: 8 week
Control Group Pain (Visual Analogue Pain Scale)
Time frame: 8 week
Control group The Pain Catastrophization Scale
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYNUR CIN, DR principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antistress Ball, The Valsalva maneuver and Skin cooling in people with Chronic Kidney Disease on Hemodialysis, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AYNUR CIN, DR (4562331053 ext. +905555565187, aynur.86.92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental group (skin cooling) The Pain Catastrophization Scale (time frame: 4 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.