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The Effect of the Hand Massage A Women Undergoing Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05937607
Recruitment Status : Enrolling by invitation
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
Sponsor:
Information provided by (Responsible Party):
Dilek Efe Arslan, TC Erciyes University

Study Description
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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
Hand Massage Behavioral: Hand massage Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 14, 2023
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. State Anxiety Scale [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05937607


Locations
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Turkey
Dilek Efe Arslan
Kayseri, Talas, Turkey, 38280
Sponsors and Collaborators
TC Erciyes University
Investigators
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Study Director: DİLEK EFE ARSLAN, PhD ERCİYES UNİVERSİTY
More Information
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Responsible Party: Dilek Efe Arslan, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT05937607    
Other Study ID Numbers: 815/795
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: July 10, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilek Efe Arslan, TC Erciyes University:
Hand Massage
Pain
State Anxiety
Brachytherapy