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Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Patients undergoing gynaecological surgery are known to experience anxiety. While the use of music selected by patients based on their personal taste has hardly been evaluated, a recent study suggests that musical preferences significantly alter the anxiolytic and relaxing effects of music. Our study aims to determine whether self-selected music decreases patient anxiety prior to gynaecological surgery, as compared with predetermined music from a software programme such as MUSIC CARE®. METHODS:The study will consist of a clinical trial comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery. A minimum of 170 patients will be randomised in a 1:1 ratio. Inclusion criteria will be: women aged 18-55 years, awaiting scheduled gynaecological surgery under general/local anaesthesia or under sedation; having created a personal 20-min playlist; and not having received anxiolytic drugs prior to surgery. The primary outcome will be the difference between the preoperative anxiety score taken 15 to 20?min before the music-listening session and the preoperative anxiety score taken shortly after the session, as measured with the STAI for state anxiety. DISCUSSION:This study should help to identify more effective non-medical treatments for preoperative anxiety, as well as to adapt music therapy to the cultural context of patients. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03226834 . Registered on 24 July 2017.

SUBMITTER: Petot T

PROVIDER: S-EPMC6323656 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial.

Petot Tiphaine T Bouscaren Nicolas N Maillard Olivier O Huiart Laetitia L Boukerrou Malik M Reynaud Danielle D

Trials 20190107 1

<h4>Background</h4>Patients undergoing gynaecological surgery are known to experience anxiety. While the use of music selected by patients based on their personal taste has hardly been evaluated, a recent study suggests that musical preferences significantly alter the anxiolytic and relaxing effects of music. Our study aims to determine whether self-selected music decreases patient anxiety prior to gynaecological surgery, as compared with predetermined music from a software programme such as MUS ...[more]

PMID: 30616674

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Project description:BackgroundAnxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman's body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity, and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).MethodsThe MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 min of music 1 h before surgery. Anxiety scores were assessed before and after the music session using Spielberger's State-Trait Anxiety Inventory (STAI).ResultsThe mean age of the 171 evaluated patients was 41.5 years (SD = 10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M = 38.8, SD = 11.9) and the intervention group (M = 39.0, SD = 13.1). After the music session, this score had significantly decreased in both the control group (M = -7.2, SD = 9.0) and the intervention group (M = -5.5, SD = 6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.ConclusionSelf-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registrationThe MUANX trial (MUsic therapy on ANXiety) is registered at the US National Institutes of Health ( ClinicalTrials.gov ) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1.

Project description:Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery).This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean?±?standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score.The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery.NCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

Project description:BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237.

Project description:The aim of the present study was to investigate the impact of preoperative music exposure on intra- and post-operative pain during cataract surgery. This study was conducted alongside a prospective single-masked randomized controlled trial (ClinicalTrials.gov NCT02892825). Patients undergoing first eye cataract surgery were included and randomly assigned to either the intervention or control group. Patients in the intervention group had a 20-min music session through earphones before surgery, while patients in the control group wore earphones without music. Anxiety level evaluated using the visual analog scale and heart rate were collected before and after music intervention. Pain level was assessed using the Numerical Pain Rating Scale, during the surgical procedure, prior to discharge and 7 days postoperatively. A total of 243 patients were included: 119 in the intervention group and 124 in the control group. No significant differences in baseline characteristics, including age, sex and rate of treated hypertension were found between the 2 groups (all p-values > 0.05). In addition, no significantly differences were found in heart rate and anxiety level before music intervention between the 2 groups (all p-values > 0.05). Conversely, anxiety level was significantly lower in the music group after the intervention (respectively, 1.3 ± 1.1 vs 3.2 ± 2.2; p < 0.05). Patients in the music group reported a lower mean pain level during surgical procedure and before discharge compared with control group (respectively, 1.2 ± 0.5 vs 2.1 ± 1.1, p = 0.03 and 0.23 ± 0.4 vs 0.81 ± 0.7, p = 0.04). No difference was found in pain level 7 days postoperatively (0.1 ± 0.3 vs 0.2 ± 0.4, p = 0.1). A significant correlation was found between anxiety level and intraoperative pain level (R = 0.64, p = 0.02). In conclusion, music intervention was effective in reducing anxiety level and self-reported pain both during surgery and in the early postoperative period. Clinical Trial Registration: https://clinicaltrials.gov/ct2/home, identifier NCT02892825.

Project description:BackgroundSurgery for pelvic organ prolapse, urinary incontinence, and hysterectomy are the most common gynaecological surgeries that can affect the function of the bladder and bowel as well as one's sexual life. There is evidence that adequate patient information given preoperatively regarding expected outcomes of surgery is important because well-informed patients are more satisfied with the results of surgery and recover faster. However, there is little known about the amount and quality of information given to women before surgery. This study investigates whether women received information before gynaecological surgery on the effect of surgery with respect to the functioning of the bladder (micturition, ability to stay continent) and the bowel (empty bowel) as well as the surgery's effect on sexual functioning.MethodsA prospective, cross-sectional study was conducted. Women undergoing hysterectomy, surgery for vaginal prolapse, or surgery for urinary incontinence (n = 972) and included in the Swedish National Register for Gynaecological Surgery participated in the study. A questionnaire was developed and distributed to the women along with the preoperative questionnaire from the register.ResultsAbout 50% of the women undergoing prolapse surgery were supplied with information regarding the effect of the surgery with respect to remaining continent, to emptying bowels, micturitaion, and sexual life. One out of four women undergoing hysterectomy received information about the effect of the surgery on the sexual life and bladder function. In the incontinence group, the given information about the surgery's effect on bladder function and sexual function was 80 and 30%, respectively.ConclusionSurgery in the vagina and the genital organs may affect function of the organs close to the surgical area (i.e., bladder and bowel) and may affect sexual function. According to this study, women are inadequately informed before surgery. Access to information via oral and written counselling needs to be improved.

Project description:ObjectivesTo examine the efficacy of intratracheal dexmedetomidine (Dex) injection for the prevention of the laryngeal response on emergence from general anaesthesia following gynaecological laparoscopic surgery.DesignProspective, randomised, double-blinded, controlled trial.SettingA general hospital, Guangdong Province, China.ParticipantsAll patients who underwent elective laparoscopic gynaecological surgery, aged 18-60 years old, 40-80?kg in weight, American Society of Anesthesiologists class I-II were eligible. Patients were excluded if they had respiratory disease, heart disorders which might represent risk factors of potential complications of Dex such as bradycardia, heart block, coronary heart disease, uncontrolled hypertension or the long-term use of sedative drugs.InterventionPatients were randomly allocated to either receive intratracheal Dex (DT), intravenous Dex (DV) or intravenous saline (CON, n=30, respectively). In the DT and DV groups, Dex (0.5?µg/kg) was diluted and mixed in 1?or 20?mL of saline, respectively, and injected via the intratracheal or intravenous route 30?min before the completion of the surgery.Outcome measuresThe primary outcome was the coughing extent among the three groups. Secondary outcomes included awareness time, extubation time, postoperative visual analogue scale and Steward recovery score.ResultsCompared with the CON group, the extent of coughing was significantly reduced in both the DV group and the DT group. Furthermore, the mean time to awareness (13.4 (4.3) vs 8.8 (2.9), p<0.001) and the extubation time (14.3 (4.3) vs 8.4 (3.6), p<0.001) were reduced in the DT group. Patients in the DT group also experienced better early recovery quality and less pain than those in the CON group. Furthermore, intratracheal Dex administration contributed to improved stability in haemodynamics with no significant side effects.ConclusionsIntratracheal Dex administration may avoid untoward laryngeal responses for patients emerging from general anaesthesia after gynaecological laparoscopy.Trial registration numberChiCTR-IOR-15007611.

Dataset Information

Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial.

Publications

Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial.

Similar Datasets

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