Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis

NCT06562959 | Completed

• 1 other identifier: AU-20-4-226-IRB00013620
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 control adherence than those who receive fluid restriction program only.

Conditions

Hemodialysis Complication

Keywords

Acupressure; Auricular; Fluid Control; Haemodialysis; Salivary Excretion; Therapeutic Adherence and Compliance

Outcome Measures

Primary Outcomes (1)

• 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).

  After one month

Secondary Outcomes (1)

• Fluid Control in Hemodialysis Patients Scale

  After one month

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions.

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.

Other: Intervention Bundle (Fluid Restriction Program and Auricular Acupressure

Interventions

Fluid Restriction Program BEHAVIORAL

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.

Control Group

Intervention Bundle (Fluid Restriction Program and Auricular Acupressure OTHER

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ranged from 6 to 18 years
• Receiving hemodialysis for at least one month

You may not qualify if:

• Diabetes Mellitus
• Heart Diseases
• Autoimmune Disorders Such as Sjogren's Syndrome

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Nursing

Alexandria, 56321, Egypt

Location

Related Publications (7)

• 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.

  PMID: 30720548 BACKGROUND

• Ahrari 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.

  PMID: 25276744 BACKGROUND

• Beerendrakumar 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.

  PMID: 29637052 BACKGROUND

• Dembowska 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.

  PMID: 36613157 BACKGROUND

• Griva 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.

  PMID: 29198641 BACKGROUND

• Chang 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.

  PMID: 34639819 BACKGROUND

• Rashwan 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.

  PMID: 40597251 DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Eman Taha, Professor

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Profesor

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: April 23, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 3, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)