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the Objectives of this clinical trial is :
Intradialytic muscles cramps are frequent complication, and common cause of early hemodialysis (HD) termination. These cramps are thought to be precipitated by intradialytic venous stasis and reduced tissue perfusion. Elastic compression stockings (ECS), compress the calf and thigh to counteract venous pooling, and increase venous return.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| compression stockings group | Experimental | Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session. |
|
| control group | No Intervention | Patients in the control group received their usual medical care during hemodialysis without any additional interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compression stockings | Device | Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the hemodialysis session. This was performed once per day for a single hemodialysis session. |
| Measure | Description | Time Frame |
|---|---|---|
| Cramp Questionnaire Chart | The instrument was developed by Morris (2014), and permission was obtained from the author. It was used in the study to assess patients' muscle cramps. This scale is composed of five features of muscle cramps: frequency, duration, pain level, leg temperature, and discomfort. These features are comprehensively scored as a level of muscle cramps ranging from 0 to 13. | Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session |
| Visual analogue scale (VAS) for pain | The Visual Analogue Scale (VAS) is a validated, subjective scale for acute and chronic pain. It was initially introduced by Hayes and Patterson in 1921. Scoring involved self-reported symptom scales that are scored with a single handwritten mark placed at a single point along a 10 cm line representing continuity between the two ends of the scale - "no pain" at the left end (0 cm) of the scale and "worst pain" at the right end of the scale (10 cm). | Baseline (pre-hemodialysis) and immediately post-hemodialysis, within a single session |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zahraa A Kareem, MGS | kerbala heath department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imam AL-Hassan AL-Mujtaba Teaching Hospital | Karbala | Karbala Governorate | Iraq | |||
| Imam Al-Hussein Medical City (Habib Ibn Mudaher Al-Asadi center) |
Individual participant data cannot be shared publicly due to ethical and confidentiality restrictions as specified in the informed consent form and approved by the Institutional Review Board.
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| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D053828 | Stockings, Compression |
| ID | Term |
|---|---|
| D058128 | Compression Bandages |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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Patients in the Compression stockings group firmly wrapped compression stockings around their calves for 30 minutes, starting at the end of the second hour and continuing until the beginning of the third hour of the HD session. This was performed once per day for a single HD session. While Patients in the control group received their usual medical care during HD without any additional interventions.
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|
| Karbala |
| Karbala Governorate |
| Iraq |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |