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Clinical Trials/NCT05937607
NCT05937607
Enrolling By Invitation
Not Applicable

The Effect of the Hand Massage Application on the Procedural Pain and State Anxiety of Women Undergoing Brachytherapy: A Parallel-Group Randomized Controlled Study

TC Erciyes University1 site in 1 country36 target enrollmentStarted: June 14, 2023Last updated:
ConditionsHand Massage

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
36
Locations
1
Primary Endpoint
Visual Analog Scale

Overview

Brief Summary

Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment.

Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. The study was completed with 36 patients. The treatment group included 18 patients, and the control group had 18. The data were collected through patient information form, visual analog scale, and state anxiety inventory. Before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. Data collection forms were repeated after each session. The control group received routine treatment. p<0.05 was accepted as significant.

Detailed Description

Therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • verbal communication
  • to be at the age of 18 and above
  • to be diagnosed with gynecologic cancer and receive BT three days a week regularly
  • to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study

Exclusion Criteria

  • the patients who had metastasis, bleeding or coagulation disorder
  • received complementary and integrated treatment
  • had edema or lesion on hand, had a psychiatric disease
  • had communication problems
  • did not want to have a massage
  • were under general anesthesia during the intervention

Outcomes

Primary Outcomes

Visual Analog Scale

Time Frame: The scale was filled in the baseline

VAS is a form including numbers and is used in rating pain. Patients mark their pain on a 10 cm ruler with painlessness 0 written on the left end and the most severe pain possible 10 on the right end. It is stated that VAS is more sensitive and dependable in pain severity measurement when compared to other one-dimensional scales

Secondary Outcomes

  • State Anxiety Scale(The scale was filled in the baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dilek Efe Arslan

Principal Investigator

TC Erciyes University

Study Sites (1)

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