The Effect of the Hand Massage A Women Undergoing Brachytherapy

NCT05937607 | Unknown DMC

• 1 other identifier: 815/795
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Massage

Keywords

Hand Massage; Pain; State Anxiety; Brachytherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State Anxiety Scale

  The scale was filled in the baseline

Study Arms (2)

Hand massage

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group did not receive any intervention during the study period

Interventions

Hand massage BEHAVIORAL

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

Hand massage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Dilek Efe Arslan

Kayseri, Talas, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• DİLEK EFE ARSLAN, PhD

  ERCİYES UNİVERSİTY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 10, 2023
• Study Start: June 14, 2023
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

TU (1)