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Hand Massage on Fatigue With Cancer Receiving Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056713
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Dilek Efe Arslan, TC Erciyes University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hand Massage Behavioral: Hand Massage Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Hand Massage on Fatigue in Women With Cancer Receiving Brachytherapy Treatment
Estimated Study Start Date : September 30, 2023
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Interventions
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
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).
No Intervention: Control Group
The control group did not receive any intervention during the study period.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study was conducted in women with gynecological cancer
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056713


Locations
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Turkey
Dilek Efe Arslan
Kayseri, Melikgazi, Turkey, 38280
Sponsors and Collaborators
TC Erciyes University
Investigators
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Study Director: DİLEK EFE ARSLAN, PhD ERCİYES UNİVERSİTY
More Information
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Responsible Party: Dilek Efe Arslan, ErciyesU, TC Erciyes University
ClinicalTrials.gov Identifier: NCT06056713    
Other Study ID Numbers: 815-795
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilek Efe Arslan, TC Erciyes University:
Hand Massage
Fatigue
Brachytherapy
Additional relevant MeSH terms:
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Fatigue