Clinical trial NCT06562959: Auricular Acupressure and Fluid Restriction Program on Salivary Flow and Fluid Adherence in Children on Hemodialysis
Official title: Effect of Integrating Auricular Acupressure and Fluid Restriction Program on Salivary Flow Rate and Fluid Control Adherence Among Children Undergoing Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Keywords: Acupressure
Auricular
Fluid Control
Haemodialysis
Salivary Excretion
Therapeutic Adherence and Compliance
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary Flow Visual Analogue Scale
timeFrame: After one month
Secondary outcomes:
measure: Fluid Control in Hemodialysis Patients Scale
timeFrame: After one month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Alexandria University
name: Eman Taha, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.