Hand Massage on Fatigue With Cancer Receiving Brachytherapy

NCT ID: NCT06056713

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2023-11-30

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.

Conditions

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Hand Massage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Hand Massage

Intervention Type BEHAVIORAL

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).

Control Group

The control group did not receive any intervention during the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Efe Arslan

ErciyesU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DİLEK EFE ARSLAN, PhD

Role: STUDY_DIRECTOR

ERCİYES UNİVERSİTY

Locations

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Dilek Efe Arslan

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Efe Arslan D, Kilic Akca N, Aslan D. The effect of hand massage on fatigue in women with cancer receiving brachytherapy: randomized clinical trial. Support Care Cancer. 2024 Dec 3;33(1):2. doi: 10.1007/s00520-024-09059-0.

Reference Type DERIVED
PMID: 39625640 (View on PubMed)

Other Identifiers

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815-795

Identifier Type: -

Identifier Source: org_study_id

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