The Effect of the Hand Massage A Women Undergoing Brachytherapy

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hand Massage
• Intervention / Treatment: Behavioral: Hand massage

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Talas
    • Kayseri, Talas, Turkey, 38280
      • Dilek Efe Arslan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand massage; hand massage was applied to the patients to receive intracavitary brachytherapy using lavender baby oil for three sessions of 10 minutes each, starting 5 minutes before the procedure.	Behavioral: Hand massage; It is reported in the literature that the application should last 5-10 minutes on average to reduce acute pain, state anxiety, and provide physiological positive changes and relaxation in individuals during the procedure
No Intervention: Control Group; The control group did not receive any intervention during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	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	The scale was filled in the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety Scale	The state anxiety scale is sensitive to the evaluation of suddenly changing emotive reactions; it is a Likert-type scale including 20 questions. The reversed items in the scale were 1st, 2nd, 5th, 8th, 10th, 11th, 15th, 16th, 19th, and 20th items. High scores indicate elevated levels of anxiety, and low scores low levels of anxiety. The total score from the scale ranges between 20 and 80.	The scale was filled in the baseline

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: DİLEK EFE ARSLAN, PhD, Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): July 15, 2023
• Study Completion (Estimated): August 15, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Brachytherapy; State Anxiety; Hand Massage
• Other Study ID Numbers: 815/795

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No