The Effect of Acupressure on Patients Receiving Brachytherapy

NCT06531551 | Enrolling By Invitation

• 1 other identifier: 18.04.24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to use acupressure to reduce anxiety in gynecologic cancer patients receiving brachytherapy. It was also aimed to investigate the effects of acupressure on anxiety, pain, and vital signs.

Conditions

Brachytherapy; Complementary Approaches; Gynecological Cancers

Keywords

Brachytherapy; Acupressure; Nursing intervention

Outcome Measures

Primary Outcomes (4)

• The State-Trait Anxiety Inventory

  The Turkish validity and reliability of the State Anxiety Scale developed by Spielberger and his team in 1970 were conducted by Öner and Le Compte (1983). This scale is used to evaluate the emotional state that an individual feels at a specific moment and under specific conditions. The scale consists of 20 items and is evaluated on a four-point Likert scale (1-not at all, 2-somewhat, 3-very much, 4-completely). The scale includes both direct statements (3, 4, 6, 7, 9, 12, 13, 14, 17, 18) and reversed statements (1, 2, 5, 8, 10, 11, 15, 16, 19, 20).In direct statements, a value of 4 indicates high anxiety, while in reverse statements, a value of 1 signifies high anxiety. The total score range is 20-80, and this scoring is interpreted as follows: "no anxiety" between 0-19, "mild anxiety" between 20-39, "moderate anxiety" between 40-59, "severe anxiety" between 60-79, and a score of 80 is considered a "panic value.

  day 1

• Visual Analog Scale

  On a 10 cm ruler with "no pain" marked at one end and "worst pain imaginable" at the other, the patient indicates their perceived level of pain. The Visual Analog Scale (VAS) is reported to be more sensitive and reliable in assessing pain intensity compared to other single-dimensional scales in the measurement of pain severity according to the Numeric Rating Scale.

  day 1

• The Hospital Anxiety and Depression Scale

  The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith in 1983 (Zigmond AS \& Snaith RP, 1983). It is stated that the scale is a reliable tool for detecting depression and anxiety in outpatient settings and provides valid measurements of the severity of emotional disorders through depression and anxiety subscales. In the scale consisting of 14 items, odd-numbered items investigate the anxiety sub-dimension, even-numbered items investigate the depression sub-dimension. It has a four-point Liket type feature between 0 and 3 points. Scoring for odd-numbered items 1, 3, 5, 6, 8, 10, 11 and 13 is 3, 2, 1, 0. Even items 2, 4, 7, 9, 12 and 14 are scored as 0,1,2,3. The scale score range is between 0-42. The cut-off score for the anxiety subscale was reported as 10, and the cut-off score for the depression subscale was reported as 7. Individuals who score above these scores constitute the risk group.

  day 1

• Vital signs

  Body temperature, Blood pressure, Pulse, Respiration; will be manually assessed by the researcher for 1 minute. Record will be made on the Personal Information Form.

  day 1

Study Arms (2)

Study

EXPERIMENTAL

Acupressure

Other: The group to which Acupressure will be applied in each fraction

Control

NO INTERVENTION

Only routine practices of the clinic will be carried out

Interventions

The group to which Acupressure will be applied in each fraction OTHER

Acupressure application protocol will be started after patient information. This process is planned to take 30 minutes.Before the application, approximately 20 seconds of warming and rubbing without direct pressure on the acupressure points will be performed to reduce tissue sensitivity and prepare the points for acupressure. Subsequently, the researcher will apply pressure with the thumb on the predetermined acupressure points, considering the individual's pain threshold, with 10 seconds of pressure followed by two seconds of relaxation without lifting the finger, in consecutive presses following the rhythm of breathing. A digital clock (belonging to the researcher) will be used to determine the duration of the acupressure application.

Study

Eligibility Criteria

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

You may qualify if:

• Being registered in Selçuk University Faculty of Medicine Hospital Radiation Oncology Polyclinic
• Brachytherapy (intracavital brachytherapy) treatment protocol will be applied due to gynecological cancer.
• to be
• Karnofsky Performance Scale being 80 and above (Performance scale for cancer patients)
• Being between the ages of 18 and 65
• Being conscious and cooperative
• Verbal and written approval to participate in the study after an explanation about the study is made.

You may not qualify if:

• Impaired skin integrity in the acupressure application area
• Refuses to participate in the study after making a statement about the study.
• Bone or spine metastasis
• Amputation of the extremities to be applied
• Not having any mental illness

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

ülkü Saygili Düzova

Selçuklu, Konya, Turkey (Türkiye)

Location

Related Publications (1)

• Duzova US, Can G, Duzova M, Basaran H, Yavas C. The effect of acupressure on anxiety, depression, pain, and vital signs in gynecological cancer patients receiving brachytherapy: A randomized controlled study. Support Care Cancer. 2025 Jul 18;33(8):698. doi: 10.1007/s00520-025-09754-6.

  PMID: 40679634 DERIVED

Study Officials

• ülkü Saygili Düzova

  Selçuk Üniversitesi Hemşirelik Fakültesi

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: August 1, 2024
• Study Start: August 28, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 10, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)