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

NCT ID: NCT06192225

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2025-11-02

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.

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Slow PACE breathing

Control arm

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Slow PACE breathing

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antoni van Leeuwenhoek hospital

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sabrine NT Hemmes, PhD

Role: CONTACT

s.hemmes@nki.nl

+20205124068

Facility Contacts

Sabrine Hemmes, MD, PhD

Role: primary

s.hemmes@nki.nl

+205124068

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 6880820 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

N23SLO

Identifier Type: -

Identifier Source: org_study_id