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NCT Number: NCT06723041

Acupressure for the Reduction of Anxiety in Patients Receiving Cancer-Directed Therapy

This clinicaI trial is being done to determine if acupressure is helpful to reduce anxiety related to chemotherapy, compared with "sham" (or placebo) acupressure in patients with cancer. Anxiety, experienced by many patients with cancer, can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicine ways to manage symptoms. Acupressure is the application of non-invasive finger pressure along energy points throughout the body in order to relieve pain and induce a feeling of well-being. Previous research has shown that acupressure can help both adults and children with their anxiety in certain situations, such as after surgery. Patients can be taught how to do the acupressure on themselves, making this an intervention that can be done anywhere. Acupressure is well tolerated with minimal reports of adverse reactions. Undergoing acupressure may be effective in reducing anxiety in cancer patients receiving chemotherapy.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

PRIMARY OBJECTIVE:

I. To test the efficacy of a nurse-applied acupressure intervention for anxiety associated with active cancer-directed therapy.

SECONDARY OBJECTIVES:

I. To test the efficacy of a patient-applied acupressure intervention for anxiety associated with active cancer-directed therapy.

II. To assess whether acupressure appears to improve nausea related to cancer and cancer-directed therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least twice daily (BID) for seven days.

ARM II: Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NURSE-LED INTERVENTION: Age >= 18 years and be diagnosed with cancer
  • NURSE-LED INTERVENTION: Undergoing systemic, antineoplastic therapy
  • NURSE-LED INTERVENTION: Ability to provide oral consent
  • NURSE-LED INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
  • NURSE-LED INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
  • NURSE-LED INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
  • SELF-ADMINISTRATION INTERVENTION: Age >= 18 years and be diagnosed with cancer
  • SELF-ADMINISTRATION INTERVENTION: Undergoing systemic, antineoplastic therapy
  • SELF-ADMINISTRATION INTERVENTION: Ability to provide oral consent
  • SELF-ADMINISTRATION INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
  • SELF-ADMINISTRATION INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
  • SELF-ADMINISTRATION INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
  • SELF-ADMINISTRATION INTERVENTION: Reports 2+/day anxiety episodes at home
  • SELF-ADMINISTRATION INTERVENTION: Interested in learning self-administered acupressure

Exclusion criteria

  • Prior experiences with acupressure, or training in acupressure points

Treatment and study plan

acupressure therapy

Procedure

Undergo true acupressure

Other names: Acupressure, Ischemic Compression

Acupressure Therapy - placebo

Procedure

Undergo sham acupressure

Other names: Acupressure, Ischemic Compression

Acupressure Therapy - self-administered

Procedure

Undergo self-administered acupressure

Other names: Acupressure, Ischemic Compression

Health Promotion and Education

Other

Receive educational handouts

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Change in acute anxiety

    Time frame: Up to 2 weeks

    Will be compared between treatment groups. This will be measured by changes in responses to a single item, "Please rate the following symptoms, based on how you feel at the current time (please indicate the one most correct response)," with responses provided on a Likert scale from 0 (no anxiety) to 10 (worst possible anxiety).

Secondary outcomes

  1. Associations between changes in anxiety and demographic variables

    Time frame: Up to 2 weeks

    Demographic variables, including age, gender identity, race/ethnicity, cancer type, cancer stage, and cancer therapy type, will be compared with answers to anxiety question specified in Outcome 1.

  2. Efficacy of self-administered acupressure

    Time frame: Up to 2 weeks

    Assessed by the number of participants in each arm (true vs sham) who are willing to complete self-administered acupressure.

  3. Changes in anxiety-related symptoms

    Time frame: Up to 2 weeks

    Assessed using an anxiety questionnaire administered at baseline and post-intervention. Seven items (anxiety, nausea, pain, wellbeing, relaxation, worry, and distress) are rated on a scale of 0 (strongly disagree) to 10 (strongly agree).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Jennifer Manggaard

CONTACT

[email protected]

507-255-7768

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Acupressure for Anxiety: A Randomized Controlled Trial of an Acupressure Intervention for Patients Receiving Cancer-Directed Therapy

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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