Hand Massage on Fatigue With Cancer Receiving Brachytherapy

Sponsor
TC Erciyes University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06056713
Collaborator
(none)
24
1
2
2
12

Study Details

Study Description

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
  • Behavioral: Hand Massage
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Brief Fatigue Inventory (BFI) [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dilek Efe Arslan Kayseri Melikgazi Turkey 38280

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Study Director: DİLEK EFE ARSLAN, PhD, ERCİYES UNİVERSİTY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dilek Efe Arslan, ErciyesU, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT06056713
Other Study ID Numbers:
  • 815-795
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dilek Efe Arslan, ErciyesU, TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023