The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Baghdad

About this trial

This randomized controlled trial aims to evaluate the effect of combined traditional and paraspinal acupressure on restless legs syndrome and pruritus among patients undergoing hemodialysis. Participants will be randomly assigned to either an intervention group receiving the acupressure intervention in addition to routine hemodialysis care or a control group receiving routine care only. The severity of restless legs syndrome and pruritus will be assessed at predetermined time points using validated assessment tools. The study aims to determine whether the combined acupressure intervention is effective in reducing restless legs syndrome and pruritus symptoms in patients undergoing hemodialysis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients more than 18 years old on hemodialysis treatment for more than 2 sessions per week.

The patients on hemodialysis for more than 3 months

The patients who complain of restless leg syndrome and pruritus.

RLS diagnosis meeting the diagnostic criteria defined by the International Restless Legs Syndrome Study Group (IRLSSG).

Disqualifiers

Patients with impaired skin integrity.

Patients with skin lesions in areas involved in acupressure therapy.

Patients with neurological deficits as perception of pain, may differ from other patients.

Patients with a body mass index (BMI) of more than > 30 kg/m².

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibration Assisted Acupressure

    Other intervention

    Vibration-assisted acupressure will be applied to selected traditional and paraspinal acupoints using a handheld vibration device. The intervention is designed to reduce the severity of restless legs syndrome and pruritus in patients undergoing hemodialysis. It will be administered according to a predefined intervention protocol in addition to routine hemodialysis care

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: intervention group (Vibration assisted acupressure)Experimental treatment 1 intervention
Group B: CONTROL GROUPNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Restless Legs Syndrome Severity Assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS)

The questionnaire consisted of 10 items, each of which had a scale ranging from 0 (no impact) to 4 (very severe impact). RLS severity was defined as mild (0-10 points), moderate (11-20 points), severe (21-30 points), or very severe (31-40 points).

Time frame
Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention
2

Change in Pruritus Severity Assessed by the 5-D Itch Scale

Pruritus severity will be assessed using the 5-D Itch Scale, which evaluates five dimensions of itching: duration, degree, direction, disability, and distribution. The total score ranges from 5 to 25, with higher scores indicating greater severity and impact of pruritus

Time frame
Baseline (before intervention), 1 month after initiation of the intervention, and 2 months after initiation of the intervention

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Al-Hussien Hemodialysis center Status unavailable 64001, Dhi-Qar, Dhi QarIraqIraq

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