Clinical trial NCT06192225: Peri-operative Slow-paced Breathing to Reduce Anxiety in Breast Cancer Surgery Patients
Official title: Peri-operative Slow-paced Breathing - a Non-invasive Technique to Reduce Anxiety in Breast Cancer Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, two-group, prospective, randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Peri operative anxiety
timeFrame: 2 weeks
Secondary outcomes:
measure: mean blood pressure before induction
timeFrame: 10 minutes
measure: need of hypnotics during induction
timeFrame: 10 minutes
measure: post-operative pain
timeFrame: post-operative on recovery (1-2hours)
measure: post-operative need of opioids
timeFrame: post-operative on recovery (1-2hours)
measure: postoperative nausea and vomiting (PONV)
timeFrame: post-operative on recovery (1-2hours)
measure: patient satisfaction
timeFrame: 5 minutes on postoperative day 1
measure: Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline
timeFrame: once at baseline, duration 10 minutes
measure: Hospital Anxiety and Depression Scale (HADS-A)
timeFrame: once at baseline, duration 10 minutes
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek hospital
Study officials:
References:
citation: Spielberger, C.D. (2010). State-Trait Anxiety Inventory. In The Corsini Encyclopedia of Psychology (eds I.B. Weiner and W.E. Craighead).
citation: 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.