Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

NCT05555524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-17

No results posted yet for this study

Summary

This study aims to evaluate the effect of cool baby oil on pruritus and sleep quality among uremic patient

Research Hypothesis:

* H01: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding sleep quality at 4 weeks follow-up
* H02: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding itching severity at 4 weeks follow-up
* H03: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding sleep quality at 12 weeks follow up
* H04: There is no difference between hemodialysis patients with uremic pruritus who apply cool baby and those who apply placebo regarding itching severity at 12 weeks follow up
* H1: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit improved sleep quality than those who apply placebo at 4 weeks follow up
* H2: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit decreased itching severity than those who apply placebo at 4 weeks follow up
* H3: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit improved sleep quality than those who apply placebo at 12 weeks follow up
* H4: Hemodialysis patients with uremic pruritus who apply cool baby oil will exhibit decreased itching severity than those who apply placebo at 12 weeks follow up

Conditions

  • Haemodialysis-Associated Pruritus

Interventions

OTHER

Baby oil

Before each application * Hand hygiene will be done * Skin care will be done to the affected area and the area is thoroughly dried. * Participants will wear a hospital gown and seated comfortably on their bed. * Gentle massage with the cool baby oil will be applied on the itching area and is continued for 15-20 min. * Message will be applied for three times a week before each hemodialysis session for 12 weeks

OTHER

Placebo

Before each application * Hand hygiene will be done * Skin care will be done to the affected area and the area is thoroughly dried. * Participants will wear a hospital gown and seated comfortably on their bed. * Gentle massage with the cool distilled water will be applied on the itching area and is continued for 15-20 min. * Message will be applied for three times a week before each hemodialysis session for 12 weeks

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Maha G Asal, Phd · Alexandria University

  • Hoda A El-Deeb, Phd · Alexandria University

  • Mona A Amer, Phd · Alexandria University

  • Mervat A Hawash, Phd · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-02
Primary Completion
2023-01-12
Completion
2023-01-12

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555524 on ClinicalTrials.gov