The Effect of the Hand Massage A Women Undergoing Brachytherapy

Sponsor
TC Erciyes University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05937607
Collaborator
(none)
36
1
2
2
17.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hand massage
N/A

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
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of the Hand Massage Application on the Procedural Pain and State Anxiety of Women Undergoing Brachytherapy: A Parallel-Group Randomized Controlled Study
Actual Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [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 Outcome Measures

  1. State Anxiety Scale [The scale was filled in the baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dilek Efe Arslan Kayseri Talas 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, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT05937607
Other Study ID Numbers:
  • 815/795
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jul 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, Principal Investigator, TC Erciyes University

Study Results

No Results Posted as of Jul 10, 2023