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

Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: pre-trained guided slow paced breathing (~6 breaths per minute)

Detailed Description

Rationale: In the perioperative period anxiety for anesthesia and the surgical procedure is common. Breast cancer surgery patients have a higher level of anxiety compared to other patients undergoing (cancer) surgery. Relaxation techniques, like breath focus with deep belly breathing are easy to learn and can have a beneficial effect on postoperative anxiety, pain, and postoperative nausea and vomiting (PONV), but the quality of evidence is low. Slow paced breathing at a frequency of 6 breaths per minute can possibly increase vagal activation, decrease anxiety, reduce mean blood pressure, and postoperative pain.

The investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, PONV and patient satisfaction.

Objective: This study aims to examine the effects of guided slow paced 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.

Study design: Single center, two-group, prospective, randomized controlled trial Study population: patients scheduled for surgery for breast cancer in the Antoni van Leeuwenhoek Hospital.

Intervention: Performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery.

Main study parameters: Anxiety scored by Spielberger's State Anxiety Inventory (STAI-S) Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to the intervention. Participants randomized in the intervention group are trained in slow paced breathing after inclusion and asked to practice the technique daily until the day of surgery. All participants are asked to complete three questionnaires at baseline, and two short questionnaires on the day of surgery and at day 1.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrine NT Hemmes, PhD; Phone Number: +20205124068; Email: s.hemmes@nki.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Recruiting
    • Antoni van Leeuwenhoek Hospital
    • Contact: Sabrine Hemmes, MD, PhD; Phone Number: +205124068; Email: s.hemmes@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Care as usual
Experimental: Slow PACE arm; 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); Slow PACE breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean blood pressure before induction	MAP (mmHg)	10 minutes
need of hypnotics during induction	total dose of hypnotics (propofol in milligrams)	10 minutes
post-operative pain	visual analoge score (VAS) for pain, 0-10 points. A VAS score > 4 indicates the need of more pain medication	post-operative on recovery (1-2hours)
post-operative need of opioids	Mean cumulative intravenous opioid dose administered during admission in the recovery room - converted to morphine equivalent dose (MEQ)	post-operative on recovery (1-2hours)
postoperative nausea and vomiting (PONV)	Y/N	post-operative on recovery (1-2hours)
patient satisfaction	scale of 0 (extremely unsatisfied) to 10 (extremely satisfied)	5 minutes on postoperative day 1
Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline	4-point scale ranging from 1 (not at all) to 4 (very much so), with 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. The STAI-T will give an estimation of patients at high risk for anxiety.	once at baseline, duration 10 minutes
Hospital Anxiety and Depression Scale (HADS-A)	A questionnaire for detecting states of anxiety and depression in a hospital setting. The HADS-A is the anxiety subscale that consists of seven items. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0 to 21. A subscale score above 8 denotes anxiety.	once at baseline, duration 10 minutes

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 2, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: N23SLO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: currently there are no other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No