Hand Massage on Fatigue With Cancer Receiving Brachytherapy

Not Applicable

• Conditions: Hand Massage
• Interventions: Behavioral: Hand Massage

• Registration Number: NCT06056713
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-09-30
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Interventions	Hand Massage	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dilek Efe Arslan; 🇹🇷 Kayseri, Melikgazi, Turkey