The Effect of Acupressure on Patients Receiving Brachytherapy

NCT ID: NCT06531551

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2024-10-10

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.

Detailed Description

Brachytherapy is a type of radiotherapy used in cancer treatment. In this method, the radiation source is placed directly on the tumor or the area to be treated. In this way, high doses of radiation are applied only to the target area, while surrounding healthy tissues are less damaged. Brachytherapy is usually used in the treatment of certain types of cancer, such as prostate, cervix, breast, and skin cancer. Gynecological brachytherapy is the application of brachytherapy in the treatment of gynecological cancers. It can be used especially in cancers of the uterus, cervix, vagina, and vulva. This treatment method is performed by placing the radiation source in the area where the tumor is located. Brachytherapy can be used in combination with surgery, chemotherapy, or other types of radiotherapy in the treatment of these types of cancers. Factors such as cancer burden, the problem of achieving remission, and the need for patients to remain immobile during the procedure, which is performed in a room that needs to be isolated due to radiation, contribute to symptoms such as pain and anxiety before and during treatment. These symptoms can sometimes affect vital signs. The need for patients to remain immobile during brachytherapy, the need to be isolated in a room due to radiation, and the discomfort caused by the applicators also increase anxiety in women. Patients often experience fear and anxiety because there is insufficient information about brachytherapy that could help relieve their pain and anxiety. Despite the complexity of such a procedure and the significant patient population, there are few studies on women's experiences with brachytherapy.

Conditions

Brachytherapy; Complementary Approaches; Gynecological Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Study

Acupressure

Group Type: EXPERIMENTAL

The group to which Acupressure will be applied in each fraction

Intervention Type: 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.

Control

Only routine practices of the clinic will be carried out

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The group to which Acupressure will be applied in each fraction

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Ülkü Saygılı

Assist. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ülkü Saygili Düzova

Role: STUDY_DIRECTOR

Selçuk Üniversitesi Hemşirelik Fakültesi

Locations

ülkü Saygili Düzova

Selçuklu, Konya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40679634 (View on PubMed)

Other Identifiers

18.04.24

Identifier Type: -

Identifier Source: org_study_id