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The Effect of Hand Massage with Violet Oil on Pruritus Level and Quality of Life in Patients Receiving Hemodialysis Treatment

NCT06756867 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-01-03

No results posted yet for this study

Summary

Itching is among the common problems in individuals receiving hemodialysis (HD) treatment. Research on the effects of aromatherapy on the symptoms seen in dialysis patients is increasing. Studies in the literature have found findings that aromatherapy reduces skin dryness and itching. This study was an experimental study with randomized intervention, placebo and control groups to determine the effect of a 7-minute massage with 2% violet oil on the hand on the non-fistula arm during the dialysis session, 3 times a week for six weeks, on the level of itching and quality of life in individuals receiving HD treatment. It was planned as. The project will be determined on individuals who are treated in 7 hemodialysis centers in a provincial center and whose itch severity scores are 3 or higher and who meet the inclusion criteria for the study.According to the results, patients who meet the inclusion criteria will be randomly assigned to intervention, placebo and control groups. Considering similar studies in the literature, the number of patients to be sampled was determined as 81 people in total, 27 per group, using the G Power program, provided that alpha = 0.05, power = 0.95 and effect size was 0.8165. Taking into account possible losses, randomization of at least 30 patients will be made to each group. Ethics committee approval and institutional permissions were obtained for the project. Verbal and written informed consent forms will be obtained from individuals. The data of the research will be collected between July 2024 and September 2024. If the required number of samples cannot be reached, the data collection process will be extended. In the study, data will be collected using the patient introduction form, 5 D Itch Scale, Kidney Disease Quality of Life Scale (KDQOLTM-36) and patient follow-up charts. In line with the massage application protocol, in addition to the treatment of patients with high itching scores, hand massage will be applied with violet oil to the individuals in the intervention group and jojoba oil to the placebo group.No action will be taken on the control group. IBM SPSS 24.0 Statistics and Turcosa programs will be used to evaluate the data. Power analysis effect size calculations will be made in the Turcosa program. It is planned to use descriptive (mean, percentage and standard deviation) and analytical statistics (Kolmogorov-Smirnov test, Kruskal-Wallis test, Wilcoxon signed rank test, Mann-Whitney Utest) in data analysis. In comparisons, a p value of \<0.05 will be considered statistically significant.

Conditions

  • Aromatherapy in Hemodialysis Patients with Itching

Interventions

OTHER

hand massage with violet oil

In this study, individuals receiving hemodialysis treatment will be massaged with 2% violet oil for 5-7 minutes on the hand on the non-fistula arm during the dialysis session, 3 times a week for six weeks.

OTHER

hand massage with jojoba oil

Hand massage with jojoba oil for hemodialysis patients 3 times a week for 6 weeks

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-01-30
Completion
2025-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756867 on ClinicalTrials.gov