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Completed

NCT Number: NCT06562959

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

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.

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Key information

Conditions

Hemodialysis Complication Behavior Health Behavior Treatment Adherence and Compliance

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Alexandria, 56321, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Fluid Control in Hemodialysis Patients Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Integrating Auricular Acupressure and Fluid Restriction Program on Salivary Flow Rate and Fluid Control Adherence Among Children Undergoing Haemodialysis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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