Hand Massage on Fatigue With Cancer Receiving Brachytherapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hand Massage

Intervention / Treatment
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* Behavioral: Hand Massage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Interventions<br>Hand massage should be done for 10 minutes, 5 minutes for each hand, before each brachytherapy (3 times in total in the 1st, 2nd and 3rd sessions). | Behavioral: Hand Massage<br>* The hand massage application lasted 10 minutes, 5 minutes on each hand, before each brachytherapy (3 times in total in the 1st, 2nd and 3rd sessions).<br>|
| No Intervention: Control Group<br>The control group did not receive any intervention during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory (BFI) | 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. | The scale was filled in the baseline (after of the Hand massage).] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand Massage, Fatigue, Brachytherapy