Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients: a Double-blind Placebo-controlled Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Haemodialysis-Associated Pruritus
• Intervention / Treatment: Other: Baby oil; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha G Asal, Phd; Phone Number: +201091200413; Email: maha-gamal@alexu.edu.eg
• Study Contact Backup: Name: Mervat A Hawash, Phd; Phone Number: +201228375304; Email: mervat.hawash@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Dialysis Units of Almowasah University Hospital
  • Alexandria, Egypt
    • Dialysis Units of the Main University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Placebo Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean itching severity score at the baseline defined by Itching Severity Scale (ISS)	this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching.	at the baseline (before assigning the participants to the study groups)
change of the mean Itching Severity Scale (ISS) at 4 weeks	this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching.	after 4 weeks from the baseline
Change of the mean Itching Severity Scale (ISS) at 12 weeks	this scale includes three items; (1) distribution of itching; (2) severity of itching; and (3) sleep disturbance caused by itching. Scores range 2-45. Increasing scores indicate increasing severity and intensity of itching.	after 12 weeks from the baseline
Mean pruritus severity Score on Visual Analog Scale at the Baseline	This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents "no itch" and the right end point the "worst imaginable itch	at the baseline (before assigning the participants to the study groups)
Change from baseline mean of the pruritus severity score on the Visual Analog Scale at 4 weeks	This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents "no itch" and the right end point the "worst imaginable itch	after 4 weeks from the baseline
Change from baseline mean of the pruritus scores on the Visual Analog Scale at 12 weeks	This scale will be used to measure the itching intensity and consisting of a 10cm long line and a single question. The left end point represents "no itch" and the right end point the "worst imaginable itch	after 12 weeks from the baseline
Mean score of the sleep quality on the Pittsburgh sleep quality index at the baseline	it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep .	at the baseline (before assigning the participants to the study groups)
Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 4 weeks	it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep .	after 4 weeks from the baseline
Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 12 weeks	it measure the self-rated sleep quality over the past month, and it is consisted of 19 self-rated question and 5 question rated by bed partner or roommate. Score ranges from 0 to 21. a score of > 5 indicate poor or difficult sleep and a score of ≤ 5 indicate good-sleep .	after 12 weeks from the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
socio-demographic and clinical data assessment tool	this tool gathers data about participants' age, gender, educational level, marital status, area of residence, and occupation, duration of disease, comorbidity disease, duration of itching, Concurrent use of antihistamine for itching, period of most intense pruritus.	(before assigning the participants to the study groups)
Related adverse Events	An unfavorable change in the health of a participants that happens during a clinical study or within a 2 days after the study has ended. This change may or may not be caused by the assigned treatment.	from starting of the intervention till 2 days after study completion

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Hoda A El-Deeb, Phd, Alexandria University; Principal Investigator: Mona A Amer, Phd, Alexandria University; Principal Investigator: Mervat A Hawash, Phd, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2022
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: 2022-9-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is not yet known if there will be a plan to make individual participant data available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No