BackgroundPatients 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®.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT03226834. Registered on 24 July 2017.
Background Anxiety 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®). Methods The 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). Results The 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. Conclusion Self-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 registration The 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
IntroductionFamily members who care for elderly people experience high levels of chronic stress because of the intensive assistance they provide permanently to those who are losing their autonomy. Often considered a burden, this stress causes serious consequences to their health and worsens their quality of life (QoL). Reducing caregivers’ chronic stress via self-hypnosis protocols may be an effective treatment. The objective is to evaluate the feasibility and acceptance of self-hypnosis protocols taught by hypnotherapy-trained nurses to reduce the chronic stress of in-family caregivers.Methods and analysisThis study is a prospective, monocentric, non-blinded, parallel, pilot, randomised waitlist-controlled trial that will be conducted at the University Hospital of Reunion Island. Sixty participants will be randomly allocated to one of two groups: a self-hypnosis group (intervention) or a waitlist control group. After an 8-week training programme, intervention participants will practice self-hypnosis for ten minutes/day over 8 weeks and subsequently be followed up for 16 weeks thereafter. The primary outcome is to assess the feasibility of a 16-week self-hypnosis protocol for in-family caregivers. Secondary outcomes include the evaluation of the effects of practising self-hypnosis among in-family caregivers of elderly people concerning their stress levels, sleep disorders, levels of fatigue, and QoL at 2, 4 and 8 months on an exploratory basis.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee CPP Ile de France VI—Groupe Hospitalier Pitié Salpêtrière on 14 April 2021 (ID RCB: 2021-A00009-32). All participants will receive information about the trial in verbal and written forms. They will give an oral consent which is notified in a dedicated research file prior before enrolment. Results will be published in peer-reviewed journals as well as presented and disseminated at conferences.Trial registration numberNCT04909970.
Background: Anxiety 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®).Methods: The 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 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The 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.Conclusion: Self-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 registration The MUANX trial 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
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