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Enrolling by invitation NCT06756867

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

No phase Interventional Aromatherapy in Hemodialysis Patients with Itching

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hand massage with violet oil, hand massage with jojoba oil.
Who it may be relevant to
Registry conditions: Aromatherapy in Hemodialysis Patients with Itching. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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

Primary outcome measures

  • 5D Itch Scale score [Time frame: 6 weeks]
Secondary outcome measures (1)
  • Kidney Disease Quality of Life Short Form- KDQOLTM-36 [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • Those aged 18 and over,
  • willing to participate in the study
  • Receiving HD treatment in HD units for at least 6 months and 3 sessions per week,
  • Continuing dialysis treatment in the same institution,
  • Patients who do not develop allergic reactions such as skin irritation, redness, burning and itching after 30 minutes by applying two drops of the oils used in the study to the outer part of the arm.
  • There was no change in the treatment program during the study period,
  • Having an itch score of 3 or above on the 5-D Itch Scale,
  • Individuals who can understand and communicate with Turkish will be included in the research.

Exclusion criteria

  • Those who have any disease of the respiratory system,
  • Those who have any allergies to the essential oils to be used,
  • Having a skin lesion in the area to be massaged,
  • Patients who use other TIT methods during the treatment process will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Erciyes University — Kayseri

Identifiers

NCT: NCT06756867 · ErciyessaglıkU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗