Hemodialysis ComplicationNCT06562959
Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis
A study testing Fluid Restriction Program and Intervention Bundle (Fluid Restriction Program and Auricular Acupressure in people with Hemodialysis Complication, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis . Hypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Fluid Restriction Program and Intervention Bundle (Fluid Restriction Program and Auricular Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2023to 3 Feb 2024
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ranged from 6 to 18 years
- Receiving hemodialysis for at least one month
Who cannot join
- Diabetes Mellitus
- Heart Diseases
- Autoimmune Disorders Such as Sjogren's Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Integrating Auricular Acupressure and Fluid Restriction Program on Salivary Flow Rate and Fluid Control Adherence Among Children Undergoing Haemodialysis
This study aims to evaluate the effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis .
Hypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid control adherence than those who receive fluid restriction program only.
Read the detailed description
A non-randomized control trial was conducted at the Hemodialysis Unit in the Alexandria University Children's Hospital. A convenient sample of 60 children undergoing Hemodialysis was randomly assigned to two parallel groups. Both groups received the fluid restriction program in three types of sessions: general small-group discussion, individualized consultations, and follow-up. The study group also received auricular acupressure on four acupoints: Shenmen, Kidney Concha, Point Zero, and Upper Tragus.
- Conditions
- Hemodialysis Complication
- Being tested
- Fluid Restriction Program, Intervention Bundle (Fluid Restriction Program and Auricular Acupressure
- Keywords
- Acupressure, Auricular, Fluid Control, Haemodialysis, Salivary Excretion, Therapeutic Adherence and Compliance
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid Restriction ProgramBehavioural
In order to design the fluid restriction program content (booklet). The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions. In the group discussion sessions, children in both the study and control groups were divided into subgroups (6 participants per each). In the group discussion sessions, children in both the study and control groups were divided into subgroups. The sessions were conducted in the meeting room of the Hemodialysis unit lasts for 45 minutes. In the Individualized Consultations, children then were provided tailored, age-appropriate education. The researchers also arranged for regular follow-up for one months.
Intervention Bundle (Fluid Restriction Program and Auricular AcupressureOther
the study group received the Fluid Restriction Program and Auricular Acupressure in four acupoints namely, Shenmen, Kidney Concha, Point Zero and Upper Tragus. The researcher's finger gently pressed on each determined acupoints in a circular movement with a clockwise direction for three minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions. Receives: Behavioral: Fluid Restriction Program |
| Study Group | Experimental | The intervention bundle, the fluid restriction program, and auricular acupressure were received at four appointments: Shenmen, Kidney Concha, Point Zero, and Upper Tragus. Receives: Other: Intervention Bundle (Fluid Restriction Program and Auricular Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Flow Visual Analogue Scale
This tool used to evaluate the salivary flow assessment. It consisted of 8 validated items measuring two main dimensions of salivary flow. The first dimension assessing the impaired oral functions due to the sensation of dry mouth as indicated by having difficulty in swallowing or speaking. While the second dimension evaluating the dryness of oral mucosa (lips, mouth, tongue, or throat). Additionally, children were asked two global questions regarding salivary quantity and thirsty level. In each item, children's responses were rated on a 100-mm horizontal numeric scale ranged from No (0) to very dry (100).
Measured: After one month
Secondary outcomes (1)
Fluid Control in Hemodialysis Patients Scale
This scale consisted of 24 items to evaluate the knowledge, behavior and attitude toward fluid restriction among patients undergoing hemodialysis. These items measure patients' compliance with fluid control.
Measured: After one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start23 Apr 2023
- Primary completion2 Feb 2024
- Study completion3 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Eman Taha, Professor, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562959
- Sponsor's protocol ID
- AU-20-4-226-IRB00013620
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.
PubMed 30720548Ahrari S, Moshki M, Bahrami M. The Relationship Between Social Support and Adherence of Dietary and Fluids Restrictions among Hemodialysis Patients in Iran. J Caring Sci. 2014 Feb 27;3(1):11-9. doi: 10.5681/jcs.2014.002. eCollection 2014 Mar.
PubMed 25276744Beerendrakumar N, Ramamoorthy L, Haridasan S. Dietary and Fluid Regime Adherence in Chronic Kidney Disease Patients. J Caring Sci. 2018 Mar 1;7(1):17-20. doi: 10.15171/jcs.2018.003. eCollection 2018 Mar.
PubMed 29637052Dembowska E, Jaron A, Gabrysz-Trybek E, Bladowska J, Trybek G. Oral Mucosa Status in Patients with End-Stage Chronic Kidney Disease Undergoing Hemodialysis. Int J Environ Res Public Health. 2023 Jan 2;20(1):835. doi: 10.3390/ijerph20010835.
PubMed 36613157Griva K, Nandakumar M, Ng JH, Lam KFY, McBain H, Newman SP. Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis. Am J Kidney Dis. 2018 Mar;71(3):371-381. doi: 10.1053/j.ajkd.2017.09.014. Epub 2017 Dec 1.
PubMed 29198641Chang A, Chung Y, Kang M. Effects of the Combination of Auricular Acupressure and a Fluid-Restriction Adherence Program on Salivary Flow Rate, Xerostomia, Fluid Control, Interdialytic Weight Gain, and Diet-Related Quality of Life in Patients Undergoing Hemodialysis. Int J Environ Res Public Health. 2021 Oct 7;18(19):10520. doi: 10.3390/ijerph181910520.
PubMed 34639819Rashwan ZI, Abdellah MMM, Moursi F, Ismail EMAE. Effect of bundling auricular acupressure and fluid restriction program on salivary flow rate and fluid control adherence among children undergoing hemodialysis: a randomized control trial. BMC Nurs. 2025 Jul 1;24(1):796. doi: 10.1186/s12912-025-03433-x.
PubMed 40597251
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrating Auricular Acupressure and Fluid Restriction Program on Salivary Flow Rate and Fluid Control Adherence Among Children Undergoing Haemodialysis
- ClinicalTrials.gov ID
- NCT06562959
- Acronym / sponsor ID
- AU-20-4-226-IRB00013620
- Conditions
- Hemodialysis Complication
- Keywords
- Acupressure, Auricular, Fluid Control, Haemodialysis, Salivary Excretion, Therapeutic Adherence and Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 3 Feb 2024 (actual)
- First posted
- 20 Aug 2024 (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 effects of auricular acupressure on salivary flow rate and fluid restriction adherence among children undergoing Hemodialysis .
Hypothesis Children undergoing Hemodialysis who receive both auricular acupressure and fluid restriction program exhibit better salivary flow rate and fluid control adherence than those who receive fluid restriction program only.
Detailed description
A non-randomized control trial was conducted at the Hemodialysis Unit in the Alexandria University Children's Hospital. A convenient sample of 60 children undergoing Hemodialysis was randomly assigned to two parallel groups. Both groups received the fluid restriction program in three types of sessions: general small-group discussion, individualized consultations, and follow-up. The study group also received auricular acupressure on four acupoints: Shenmen, Kidney Concha, Point Zero, and Upper Tragus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Fluid Restriction ProgramThe fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions. |
| Study Group | Experimental | Other: Intervention Bundle (Fluid Restriction Program and Auricular AcupressureThe intervention bundle, the fluid restriction program, and auricular acupressure were received at four appointments: Shenmen, Kidney Concha, Point Zero, and Upper Tragus. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age ranged from 6 to 18 years
- Receiving hemodialysis for at least one month
Key exclusion criteria (3 listed)
- Diabetes Mellitus
- Heart Diseases
- Autoimmune Disorders Such as Sjogren's Syndrome
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 |
|---|---|---|
| Fluid Restriction ProgramIn order to design the fluid restriction program content (booklet). The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions. In the group discussion sessions, children in both the study and control groups were divided into subgroups (6 participants per each). In the group discussion sessions, children in both the study and control groups were divided into subgroups. The sessions were conducted in the meeting room of the Hemodialysis unit lasts for 45 minutes. In the Individualized Consultations, children then were provided tailored, age-appropriate education. The researchers also arranged for regular follow-up for one months. | Behavioural | Control Group |
| Intervention Bundle (Fluid Restriction Program and Auricular Acupressurethe study group received the Fluid Restriction Program and Auricular Acupressure in four acupoints namely, Shenmen, Kidney Concha, Point Zero and Upper Tragus. The researcher's finger gently pressed on each determined acupoints in a circular movement with a clockwise direction for three minutes. | Other | Study Group |
Primary outcome
Salivary Flow Visual Analogue Scale
Time frame: After one month
This tool used to evaluate the salivary flow assessment. It consisted of 8 validated items measuring two main dimensions of salivary flow. The first dimension assessing the impaired oral functions due to the sensation of dry mouth as indicated by having difficulty in swallowing or speaking. While the second dimension evaluating the dryness of oral mucosa (lips, mouth, tongue, or throat). Additionally, children were asked two global questions regarding salivary quantity and thirsty level. In each item, children's responses were rated on a 100-mm horizontal numeric scale ranged from No (0) to very dry (100).
1 secondary outcome
Fluid Control in Hemodialysis Patients Scale
Time frame: After one month
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 20 Aug 2024.
- Background: PubMed 30720548Ozen N, Cinar FI, Askin D, Mut D, Turker T. Nonadherence in Hemodialysis Patients and Related Factors: A Multicenter Study. J Nurs Res. 2019 Aug;27(4):e36. doi: 10.1097/jnr.0000000000000309.
- Background: PubMed 25276744Ahrari S, Moshki M, Bahrami M. The Relationship Between Social Support and Adherence of Dietary and Fluids Restrictions among Hemodialysis Patients in Iran. J Caring Sci. 2014 Feb 27;3(1):11-9. doi: 10.5681/jcs.2014.002. eCollection 2014 Mar.
- Background: PubMed 29637052Beerendrakumar N, Ramamoorthy L, Haridasan S. Dietary and Fluid Regime Adherence in Chronic Kidney Disease Patients. J Caring Sci. 2018 Mar 1;7(1):17-20. doi: 10.15171/jcs.2018.003. eCollection 2018 Mar.
- Background: PubMed 36613157Dembowska E, Jaron A, Gabrysz-Trybek E, Bladowska J, Trybek G. Oral Mucosa Status in Patients with End-Stage Chronic Kidney Disease Undergoing Hemodialysis. Int J Environ Res Public Health. 2023 Jan 2;20(1):835. doi: 10.3390/ijerph20010835.
- Background: PubMed 29198641Griva K, Nandakumar M, Ng JH, Lam KFY, McBain H, Newman SP. Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis. Am J Kidney Dis. 2018 Mar;71(3):371-381. doi: 10.1053/j.ajkd.2017.09.014. Epub 2017 Dec 1.
- Background: PubMed 34639819Chang A, Chung Y, Kang M. Effects of the Combination of Auricular Acupressure and a Fluid-Restriction Adherence Program on Salivary Flow Rate, Xerostomia, Fluid Control, Interdialytic Weight Gain, and Diet-Related Quality of Life in Patients Undergoing Hemodialysis. Int J Environ Res Public Health. 2021 Oct 7;18(19):10520. doi: 10.3390/ijerph181910520.
- Derived from this study: PubMed 40597251Rashwan ZI, Abdellah MMM, Moursi F, Ismail EMAE. Effect of bundling auricular acupressure and fluid restriction program on salivary flow rate and fluid control adherence among children undergoing hemodialysis: a randomized control trial. BMC Nurs. 2025 Jul 1;24(1):796. doi: 10.1186/s12912-025-03433-x.
- Individual participant dataSharing planned: No
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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.
Eman Taha, Professor study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Restriction Program and Intervention Bundle (Fluid Restriction Program and Auricular Acupressure in people with Hemodialysis Complication, run by Alexandria University at 1 site 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 2 inclusion and 3 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Salivary Flow Visual Analogue Scale (time frame: After one month). 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 NCT06562959, which also lists 7 linked publications.
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 20 Aug 2024.