Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients

NCT05555524 | Completed

• 1 other identifier: 2022-9-43
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Haemodialysis-Associated Pruritus

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• socio-demographic and clinical data assessment tool

  (before assigning the participants to the study groups)

• Related adverse Events

  from starting of the intervention till 2 days after study completion

Study Arms (2)

Baby oil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Baby oil 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

Baby oil

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Dialysis Units of Almowasah University Hospital

Alexandria, Egypt

Location

Dialysis Units of the Main University Hospital

Alexandria, Egypt

Location

Study Officials

• Maha G Asal, Phd

  Alexandria University

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A two computer allocation sequence will be generated. They will be placed in an opaque, sealed envelope and kept with the head nurse of each hemodialysis unit. After completing the baseline data, the clinical researchers open the envelops and assign the patients to one group. The baby oil and the placebo distilled water will be placed on identical bottles and participants will not be informed about group assignments. The clinical researcher will label the groups as A or B; only the clinical researchers will know the group allocation. Both the outcome assessor and the statistician will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: two-group pre-test and repeated post-test study

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: October 2, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

EG (2)