Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients

NCT06192225 | Unknown

• 1 other identifier: N23SLO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single-center trial is to examine the effects of a slow-breathing technique performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S),13 compared to usual care.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Peri operative anxiety

  The present study aims to examine the effects of pre-trained guided Slow PACE breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by Spielberger's State-Trait Anxiety Inventory, state scale (STAI-S), compared to usual care. The total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety symptoms. A cut-off score of 40 is commonly used to define probable clinical levels of anxiety.

  2 weeks

Secondary Outcomes (8)

• mean blood pressure before induction

  10 minutes

• need of hypnotics during induction

  10 minutes

• post-operative pain

  post-operative on recovery (1-2hours)

• post-operative need of opioids

  post-operative on recovery (1-2hours)

• postoperative nausea and vomiting (PONV)

  post-operative on recovery (1-2hours)

Study Arms (2)

Slow PACE arm

EXPERIMENTAL

The intervention consists of performance of pre-trained guided Slow PACE breathing by the patient at induction of anesthesia for breast cancer surgery.

Behavioral: pre-trained guided slow paced breathing (~6 breaths per minute)

Control arm

NO INTERVENTION

Care as usual

Interventions

pre-trained guided slow paced breathing (~6 breaths per minute) BEHAVIORAL

Slow PACE breathing

Slow PACE arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Population of patients with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Undergoing surgery for breast cancer in the Antoni van Leeuwenhoekziekenhuis

You may not qualify if:

• Age \< 18 years
• ASA ≥ 4
• History of severe pulmonary illness: severe asthma or severe chronic obstructive pulmonary disease (COPD) GOLD III or IV
• Known or suspected severe psychiatric disorder
• Unable to give written or oral informed consent
• Patient refusal
• Not able to understand Dutch
• No internet access
• Visual or hearing impairments interfering with reading and listening to the online material

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Antoni van Leeuwenhoek hospital

Amsterdam, 1066 CX, Netherlands

RECRUITING

Related Publications (2)

• Spielberger, C.D. (2010). State-Trait Anxiety Inventory. In The Corsini Encyclopedia of Psychology (eds I.B. Weiner and W.E. Craighead).

  BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Sabrine NT Hemmes, PhD

CONTACT

+20205124068; s.hemmes@nki.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, two-group, prospective, randomized controlled trial

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: January 5, 2024
• Study Start: November 29, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 2, 2025
• Last Updated: January 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)