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The goal of this clinical trial is to assess whether press needle acupuncture (PN) is more effective than sham press needle (sham PN) in reducing pruritus in patients with chronic kidney disease-associated pruritus (CKDaP) undergoing hemodialysis. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The press needle, antihistamine and moisturizer therapy |
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| Control Group | Sham Comparator | The sham press needle, antihistamine and moisturizer therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The press needle, antihistamine, and moisturizer therapy | Device | Device: Press Needle (PN) PN is applied unilaterally on acupoints LI11, SP10, ST36, and SP6 alternately. It consists of an adhesive patch with a small sterile needle retained for 3-4 days before replacement. This procedure is repeated over a 4-week period. Needle sizes is 0.22 × 1.5 mm), and all procedures follow standard aseptic protocols. PN provides prolonged stimulation with cumulative effects in a minimally invasive manner. Participants continue their routine hemodialysis and conventional treatments for CKD-associated pruritus (CKDaP). |
| Measure | Description | Time Frame |
|---|---|---|
| 5-D Pruritus Scale | Pruritus severity will be assessed using the validated 5-D Pruritus Scale, which evaluates five dimensions: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating more severe pruritus. | Baseline, after 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment |
| Adverse events | Any adverse events related to the intervention, including pain, bleeding, skin irritation, or infection at the site of application, will be recorded and monitored. | After 2nd, 4th, 6th, and 8th treatment sessions, and 4 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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The press needle, antihistamine, and moisturizer therapy will be designted as the intervention group, while the sham press needle, antihistamine, and moisturizer therapy will be designated as the control group.
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The participant and outcomes assessor will be blinded to group allocation.
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| The sham press needle, antihistamine and moisturizer therapy | Device | Sham PN uses adhesive patches without needles, applied to the same acupoints (LI11, SP10, ST36, and SP6) with the same retention schedule (3-4 days over 4 weeks) as the intervention group. All procedures, including placement and instructions, are performed identically to maintain blinding. There is no skin penetration or real acupoint stimulation. Participants continue their routine hemodialysis and conventional treatments for CKDaP. |
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