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

Not Applicable

Completed

• Conditions: Hemodialysis Complication
• Interventions: Behavioral: Fluid Restriction Program; Other: Intervention Bundle (Fluid Restriction Program and Auricular Acupressure

• Registration Number: NCT06562959
• Lead Sponsor: Alexandria University

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.

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 Timeline

• Study Start: 2023-04-23
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-03
• Status Verified: 2024-08
• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Fluid Restriction Program	The fluid restriction program included (a) General small-group discussion sessions, (b) individualized consultations, and (c) follow-up sessions.
Study Group	Intervention Bundle (Fluid Restriction Program and Auricular Acupressure	The intervention bundle, the fluid restriction program, and auricular acupressure were received at four appointments: Shenmen, Kidney Concha, Point Zero, and Upper Tragus.

Primary Outcome Measures

Name	Time	Method
Salivary Flow Visual Analogue Scale	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).

Secondary Outcome Measures

Name	Time	Method
Fluid Control in Hemodialysis Patients Scale	After one month	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.

Trial Locations

Locations (1)

Faculty of Nursing; 🇪🇬 Alexandria, Egypt