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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
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
|
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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
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
Turkey | |
Dilek Efe Arslan | |
Kayseri, Talas, Turkey, 38280 |
Study Director: | DİLEK EFE ARSLAN, PhD | ERCİYES UNİVERSİTY |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hand Massage Pain State Anxiety Brachytherapy |