Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

NCT ID: NCT05555524

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-02
• Study Completion Date: 2023-01-12

Brief 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

Detailed Description

Treatment of uremic pruritus is difficult due to the refractory nature of the disease, resulting in poor hemodialysis patient quality of life, pharmacological therapy is the most common clinical treatment method. Unfortunately, despite these interventions, pruritus remains a chronic problem for many dialysis patients. Recently, non-pharmacological interventions are effective for hemodialysis patients with uremic pruritus. Emollients that include Petrolatum, lanolin, mineral oil, and dimethicone were very effective, readily available, and cost-effective interventions in comparison to other methods to improve pruritus symptoms. Several studies have been conducted and show the efficiency of baby oil in controlling pruritus and enhancing sleep quality among hemodialysis patients. However these studies evaluate the short-term effect (4 weeks), Although these studies employed usual care, no-treatment group as the control condition, thus it was not possible to blind the participants. This type of control group would likely increase treatment effects from baby oil by comparison. Thus the current study will be conducted to evaluate the effect of baby oil on pruritus and sleep quality compared to a placebo control at 4 and 12 weeks followup.

Conditions

Haemodialysis-Associated Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Baby oil

A cool commercial baby oil at a temperature between 10°C and 15°C that composed of Paraffinum Liquidum, Isopropyl Palmitate, Parfumwill be applied to the affected area for a period of 15-20 min for three times a week before each hemodialysis session for 12 weeks.

the baby oil bottle will be stored at the refrigerator.

Group Type: EXPERIMENTAL

Baby oil

Intervention Type: OTHER

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

Placebo

A cool distilled water at a temperature between 10°C and 15°C with added two drops of the baby oil to each 100 cc will be applied to the affected area for a period of 15-20 min for three times a week before each hemodialysis session for 12 weeks.

the distilled water will be put at an identical bottle as the baby oil bottle and stored at the refrigerator.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having three episodes of itching (each episode 5 min or longer) within the last 2 weeks
• Having intermittent itching complaints during the last 6 month
• Agreed to be on a fixed dose of the medical treatment throughout the study

Exclusion Criteria

• Open wound
• Skin infection
• Edema
• History of allergic reaction to the oils
• Liver and dermatological diseases
• Usage of other treatment rather than the medical treatment on a regular basis 2 weeks prior to randomization and throughout the study
• Currently participating in other clinical trials

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Maha Gamal Ramadan Asal

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha G Asal, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Hoda A El-Deeb, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Mona A Amer, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Mervat A Hawash, Phd

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Dialysis Units of Almowasah University Hospital

Alexandria, , Egypt

Dialysis Units of the Main University Hospital

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

2022-9-43

Identifier Type: -

Identifier Source: org_study_id