Haemodialysis-Associated PruritusNCT05555524
Cool Baby Oil for Pruritus and Sleep Quality Among Uremic Patients
A study testing Baby oil in people with Haemodialysis-Associated Pruritus, run by Alexandria University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis-Associated Pruritus
- What is being tested?
- Baby oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Oct 2022to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Dialysis Units of Almowasah University Hospital
Alexandria
Dialysis Units of the Main University Hospital
Alexandria
About this study
Official title: 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
Read the 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
- Being tested
- Baby oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby oilOther
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: after 12 weeks from the baseline
Secondary outcomes (2)
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.
Measured: (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.
Measured: from starting of the intervention till 2 days after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start2 Oct 2022
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis-Associated PruritusStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-group pre-test and repeated post-test study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Gamal Ramadan Asal, Alexandria University
- Investigators
- Maha G Asal, Phd, Principal investigator, Alexandria UniversityHoda A El-Deeb, Phd, Principal investigator, Alexandria UniversityMona A Amer, Phd, Principal investigator, Alexandria UniversityMervat A Hawash, Phd, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555524
- Sponsor's protocol ID
- 2022-9-43
- Status last verified
- Jan 2023
- First submitted
- 22 Sep 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make individual participant data available.
Publications
Asal MGR, El-Deeb HAAE, Amer MAE, Hawash MAH. Cool baby oil for pruritus and sleep quality among uremic patients: a nurse-led randomized controlled trial. BMC Nurs. 2025 Dec 23;25(1):87. doi: 10.1186/s12912-025-03952-7.
PubMed 41437348
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cool Baby Oil on Pruritus and Sleep Quality Among Uremic Patients: a Double-blind Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05555524
- Acronym / sponsor ID
- 2022-9-43
- Conditions
- Haemodialysis-Associated Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two-group pre-test and repeated post-test study
| Arm | Type | Receives |
|---|---|---|
| Baby oil | Experimental | Other: Baby oilA 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. |
| Placebo | Placebo comparator | Other: PlaceboA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Open wound
- Skin infection
- Edema
- History of allergic reaction to the oils
- Liver and dermatological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby oilBefore 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 | Baby oil |
| PlaceboBefore 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 | Other | Placebo |
Primary outcome
mean itching severity score at the baseline defined by Itching Severity Scale (ISS)
Time frame: at the baseline (before assigning the participants to the study groups)
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.
change of the mean Itching Severity Scale (ISS) at 4 weeks
Time frame: after 4 weeks from the baseline
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.
Change of the mean Itching Severity Scale (ISS) at 12 weeks
Time frame: after 12 weeks from the baseline
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.
Mean pruritus severity Score on Visual Analog Scale at the Baseline
Time frame: at the baseline (before assigning the participants to the study groups)
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
Change from baseline mean of the pruritus severity score on the Visual Analog Scale at 4 weeks
Time frame: after 4 weeks from 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
Change from baseline mean of the pruritus scores on the Visual Analog Scale at 12 weeks
Time frame: after 12 weeks from 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
Mean score of the sleep quality on the Pittsburgh sleep quality index at the baseline
Time frame: at the baseline (before assigning the participants to the study groups)
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 .
Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 4 weeks
Time frame: after 4 weeks from 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 .
Change from baseline mean of the sleep quality on the Pittsburgh sleep quality index at 12 weeks
Time frame: after 12 weeks from 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 .
2 secondary outcomes
socio-demographic and clinical data assessment tool
Time frame: (before assigning the participants to the study groups)
Related adverse Events
Time frame: from starting of the intervention till 2 days after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 41437348Asal MGR, El-Deeb HAAE, Amer MAE, Hawash MAH. Cool baby oil for pruritus and sleep quality among uremic patients: a nurse-led randomized controlled trial. BMC Nurs. 2025 Dec 23;25(1):87. doi: 10.1186/s12912-025-03952-7.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha G Asal, Phd principal investigator
Alexandria University
Hoda A El-Deeb, Phd principal investigator
Alexandria University
Mona A Amer, Phd principal investigator
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby oil in people with Haemodialysis-Associated Pruritus, run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean itching severity score at the baseline defined by Itching Severity Scale (ISS) (time frame: at the baseline (before assigning the participants to the study groups)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.