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Clinical Trials/NCT06056713
NCT06056713
Enrolling By Invitation
Not Applicable

The Effect of Hand Massage on Fatigue in Women With Cancer Receiving Brachytherapy Treatment

TC Erciyes University1 site in 1 country24 target enrollmentSeptember 30, 2023
ConditionsHand Massage

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hand Massage
Sponsor
TC Erciyes University
Enrollment
24
Locations
1
Primary Endpoint
Brief Fatigue Inventory (BFI)
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

This randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving BT therapy. Randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in Turkey. When 12 patients were included in each group, it was determined that the power was 90% at the 5% Type I error level, and a total of 24 women with gynecological cancer were included in the study. The primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. Patient Information Form and Brief Fatigue Inventory (BFI) used. This study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.

Detailed Description

Therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving BT therapy. . This randomized clinical trial was conducted.

Registry
clinicaltrials.gov
Start Date
September 30, 2023
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dilek Efe Arslan

ErciyesU

TC Erciyes University

Eligibility Criteria

Inclusion Criteria

  • 18 years and over,
  • underwent BT regularly
  • Patients who volunteered to participate in the study

Exclusion Criteria

  • Having skin problems
  • with metastases,
  • have bleeding or coagulation disorders,
  • using complementary integrated therapy during the study,
  • Having edema or wound in the hand area,
  • not wanting to get a massage
  • Patients receiving general anesthesia during the procedure

Outcomes

Primary Outcomes

Brief Fatigue Inventory (BFI)

Time Frame: The scale was filled in the baseline (after of the Hand massage).]

The BFI, developed by Mendoza et al. (1999), was used to rapidly assess the severity and impact of cancer-related fatigue on daily living activities \[33\]. This inventory has nine items and measures fatigue severity (questions 1, 2, and 3) and fatigue interference in daily life activities (questions 4a, 4b, 4c, 4d, 4e, and 4f). Its reliability and validity, in the Turkish context, were determined by Usta Yeşilbalkan and Karadakovan (2005) and had a Cronbach's alpha value of Turkish version of 0.97 \[34\]. Each item of the BFI that consists of 9 items takes a value between 0-10 points.; higher scores indicate greater fatigue scores. Fatigue severity score is calculated by nine items and whereas fatigue interference score is calculated by summation of questions 4a, 4b, 4c, 4d, 4e, and 4f.

Study Sites (1)

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