Anxiety
Conditions
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.
Interventions
BEHAVIORALpre-trained guided slow paced breathing (~6 breaths per minute)
Slow PACE breathing
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single center, two-group, prospective, randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri operative anxiety | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need of hypnotics during induction | 10 minutes | total dose of hypnotics (propofol in milligrams) |
| post-operative pain | post-operative on recovery (1-2hours) | visual analoge score (VAS) for pain, 0-10 points. A VAS score \> 4 indicates the need of more pain medication |
| post-operative need of opioids | post-operative on recovery (1-2hours) | Mean cumulative intravenous opioid dose administered during admission in the recovery room - converted to morphine equivalent dose (MEQ) |
| mean blood pressure before induction | 10 minutes | MAP (mmHg) |
| patient satisfaction | 5 minutes on postoperative day 1 | scale of 0 (extremely unsatisfied) to 10 (extremely satisfied) |
| Anxiety trait scored by Spielberger's State Anxiety Inventory (STAI-T)13 at baseline | once at baseline, duration 10 minutes | 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. |
| Hospital Anxiety and Depression Scale (HADS-A) | once at baseline, duration 10 minutes | 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. |
| postoperative nausea and vomiting (PONV) | post-operative on recovery (1-2hours) | Y/N |
Countries
Netherlands
Contacts
Primary ContactSabrine NT Hemmes, PhD
Outcome results
None listed