- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07748078
Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
Impact of Snoezelen Therapy in Adults With Alcohol Dependence and Adults With Schizophrenia
The purpose of the study: obtaining knowledge about the impact of Snoezelen® therapy on the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol.
The main questions it aims to answer are:
Does Snoezelen therapy improve the health of adults suffering from schizophrenia and requiring permanent institutional care, adults suffering from schizophrenia and adults (women) addicted to alcohol?
The participant will participate in Snoezelen® therapy for 6 or 12 weeks, 2 times a week (30 minutes each session).
연구 개요
상태
상세 설명
Snoezelen® room, as a multisensory interaction environment that has been widely used in studies involving older adults, people with neurological conditions (including children and adults with disabilities), neurodegenerative conditions, and people struggling with depressive and anxiety disorders. Scientific evidence indicates a significant reduction in depression and anxiety levels in people using Snoezelen® therapy, as well as an improvement in the quality of life of people with intellectual disabilities. In a recent case study, Snoezelen® therapy improved emotion recognition and the development of emotional functions in a patient with alexithymia, highlighting the potential of this therapy in psychiatric rehabilitation.
To date, few scientific studies of Snoezelen® therapy have been conducted with psychiatric patients, as confirmed by a recent review (Hudon et al. 2023). There have also been no studies of Snoezelen® therapy specifically targeting groups of patients struggling with addiction or schizophrenia. The lack of scientific evidence regarding the potential impact of Snoezelen® therapy on improving outcomes in psychiatric patients prompted the development of this study to better understand the effectiveness of the therapy in this patient group.
The results obtained in the study will be innovative and will allow us to answer the question whether therapy in the Snoezelen ® room in people suffering from schizophrenia and adults with alcohol addiction will result in improved cognitive functioning, organization of daily activities, improvement in the negative symptoms of schizophrenia, improvement in mood, including a reduction in emotions such as anxiety and sadness, as well as an increase in the patient's overall quality of life and emotional intelligence.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alicja Kosmalska, MD
- 전화번호: 032 43 28 217
- 이메일: alicja.kosmalska@psychiatria.com
연구 연락처 백업
- 이름: Laura Piejko, PT, PhD
- 전화번호: 032 43 28 185
- 이메일: laura.piejko@psychiatria.com
연구 장소
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, 폴란드, 40-065
- Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
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연락하다:
- Laura Piejko, PT, PhD
- 전화번호: 32 207 51 10
- 이메일: l.piejko@awf.katowice.pl
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수석 연구원:
- Laura Piejko, PT, PhD
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Rybnik, Silesian Voivodeship, 폴란드, 44-200
- Clinical Psychiatric Hospital SPZOZ in Rybnik, Poland
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연락하다:
- Alicja Kosmalska, MD
- 전화번호: 032 43 28 217
- 이메일: alicja.kosmalska@psychiatria.com
-
연락하다:
- Laura Piejko, PT, PhD
- 전화번호: 032 43 28 185
- 이메일: laura.piejko@psychiatria.com
-
수석 연구원:
- Alicja Kosmalska, MD
-
수석 연구원:
- Laura Piejko, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Adults suffering from schizophrenia requiring permanent institutional care, N=40
Inclusion criteria:
- women and men aged ≥ 18 years,
- consent of the patient or legal guardian to participate in the study,
- schizophrenia clinically confirmed for at least 5 years, with predominance of negative symptoms,
- stable drug therapy (treatment unchanged for at least 3 months)
- ability to understand and follow the therapist's instructions,
- functional ability of everyday life on the Barthel scale below 40 points,
Exclusion criteria:
- lack of consent to participate in the study;
- pregnancy;
- general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
- unstable or untreated epilepsy, based on EEG;
- exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
- active cancer disease;
- diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
- diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
Adults (men) suffering from schizophrenia, N=40
Inclusion criteria:
- men aged ≥ 18 years,
- consent of the patient or legal guardian to participate in the study,
- clinically confirmed schizophrenia with predominance of negative symptoms,
- stable drug therapy (treatment unchanged for at least 1 month),
- ability to understand and follow the therapist's instructions,
- functional ability of everyday life on the Barthel scale above 40 points,
Exclusion criteria:
- lack of consent to participate in the study;
- general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
- unstable or untreated epilepsy, based on EEG;
- exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
- active cancer disease;
- diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli; diseases and illnesses of the musculoskeletal system disturbing body balance and limb mobility.
- Adults (women) addicted to alcohol, N= 60
Inclusion criteria:
- female gender;
- age ≥ 18 years;
- consent of the patient or legal guardian to participate in the study;
- alcohol dependence syndrome (F10.2 according to ICD-10);
- history of depressive and anxiety symptoms;
- ability to understand and follow the therapist's instructions;
- functional ability of everyday life on the Barthel scale above 40 points.
Exclusion criteria:
- lack of consent to participate in the study;
- pregnancy;
- psychoactive substances other than alcohol;
- exacerbation of the main disease (acute psychosis, severe anxiety, tendency to active aggression, etc.);
- mental illnesses other than depression and anxiety disorders;
- psychotic diseases (F20- schizophrenia and other schizophrenic disorders);
- general contraindications (acute inflammatory and febrile diseases, venous thrombosis, unstable arterial hypertension, early condition after contrast computed tomography, early condition after lumbar puncture, general serious condition of the patient);
- unstable or untreated epilepsy, based on EEG;
- active cancer disease;
- diseases of the nervous system (neuropathies, stroke, damage to the cerebellum, labyrinth, Parkinson's disease) causing altered sensitivity to stimuli;
- severe cognitive impairment;
- diagnosis of autism and ADHD;
- PTSD;
- intellectual disability (diagnosis F70 - F79);
- diseases and illnesses of the musculoskeletal system that disturb the body's balance and the mobility of the limbs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Standard Therapy in Control Group
In all control groups, for ethical reasons, a standard therapy based on the principles of best clinical practice will be conducted. There will be 3 control groups:
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실험적: adults suffering from schizophrenia requiring permanent institutional care
Adults suffering from schizophrenia requiring permanent institutional care, N= 20 Snoezelen® therapy will be conducted twice a week (for 30 minutes) for 12 weeks. The goal of the therapy will be to improve cognitive functioning, organization in daily activities, mood, including reducing emotions such as anxiety and sadness, and to increase the patient's overall quality of life. |
Description: The each session of Snoezelen® therapy will last 30 minutes and will include: a) preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems, b) careful observation and appropriate care of the patient, c) grading of stimuli and their appropriate stimulation, d) experiencing therapeutic activities together with the patient, e) recording the therapist's presence and comments on the therapy card.
다른 이름들:
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실험적: Adults suffering from schizophrenia
Adults suffering from schizophrenia, N= 20 Snoezelen® therapy will be conducted twice a week (for 30 minutes) for 12 weeks. The goal of the therapy will be to improve cognitive functioning, organization of daily activities, mood improvement, including reducing emotions such as anxiety and sadness, as well as increasing the patient's overall quality of life and emotional intelligence. |
Description: The each session of Snoezelen® therapy will last 30 minutes and will include: a) preparation and adjustment of stimuli based on information regarding the assessment of the patient's condition and problems, b) careful observation and appropriate care of the patient, c) grading of stimuli and their appropriate stimulation, d) experiencing therapeutic activities together with the patient, e) recording the therapist's presence and comments on the therapy card.
다른 이름들:
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실험적: patients (women) treated for alcohol addiction
Patients (women) treated for alcohol addiction, N= 30. Snoezelen ® therapy will be used twice a week (for 30 minutes) for 6 weeks. Then, 4 weeks after the end of therapy (so-called follow-up ), a telephone interview will be conducted to assess mood and the short Penn Alcohol Craving Scale. The goal of the therapy will be to improve cognitive functioning, organization of daily activities, mood improvement, including reducing emotions such as anxiety and sadness, as well as increasing the patient's overall quality of life and emotional intelligence. |
The each session of Snoezelen® therapy will last 30 minutes and will include:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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outcomes in patients suffering from schizophrenia requiring institutional care - MOCA or ACE-III
기간: From enrollment to the end of treatment at 12 weeks
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1. Cognitive function testing using the MOCA or ACE-III
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia requiring institutional care - BDI or GDS
기간: From enrollment to the end of treatment at 12 weeks
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Emotional state examination, which will be carried out by determining the degree of: a. Severity of depressive symptoms using the BDI or GDS scale.
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia requiring institutional care - Burns Anxiety Inventory
기간: From enrollment to the end of treatment at 12 weeks
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Emotional state examination, which will be carried out by determining the b.
Anxiety levels using the Burns Anxiety Inventory The questionnaire consists of 33 questions divided into three main categories, which the patient rates based on their experience over the past week: Anxious feelings - 6 items (e.g., nervousness, sense of impending doom, panic attacks).
Anxious thoughts - 11 items (e.g., fear of losing control, fear of going crazy or becoming physically ill).
Physical symptoms - 16 items (e.g., heart palpitations, dizziness, muscle tension, shortness of breath).
Scoring: Each of the 33 questions is rated on a 4-point Likert scale from 0 to 3 points: 0 - Not at all / did not bother 1 - A little / slightly 2 - Moderate 3 - Very much.
The total score ranges from 0 to 99 points.
Interpretation of results: 0-4 points: Minimal or no anxiety, 5-10 points: Anxiety very mild, 11-20 points: Mild anxiety, 21-30 points: Moderate anxiety, 31-50 points: Severe anxiety.
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia requiring institutional care - SWLS
기간: From enrollment to the end of treatment at 12 weeks
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Life satisfaction using the SWLS scale The SWLS (Satisfaction with Life Scale) is a short psychological tool used to assess overall life satisfaction.
It consists of five statements, which the respondent rates on a seven-point scale.
It is intended for adults, both healthy and sick, and takes approximately two minutes to complete.
The scasle contains five statements regarding satisfaction with one's overall life.
Response Format: Seven-point Likert scale (from 1 - I completely disagree to 7 - I completely agree).
Score: overall life satisfaction index = the higher the score, the greater the sense of satisfaction.
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia requiring institutional care - Barthel Scale
기간: From enrollment to the end of treatment at 12 weeks
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Examination of activities of daily living using the Barthel scale.
The Barthel Scale is a popular medical tool used to assess a patient's independence in 10 basic activities of daily living, such as eating, dressing, and using the toilet.
The maximum score is 100 points, and the score indicates the patient's need for assistance from others.
Interpretation of scores: 85-100 points: good condition, the patient is independent.
21-84 points: moderate or moderately severe disability, the patient requires varying degrees of assistance.
0-20 points: severe disability, the patient is completely dependent on others (a score of 40 or less qualifies the patient for long-term care).
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia requiring institutional care - blood test
기간: From enrollment to the end of treatment at 12 weeks
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Blood concentration testing for selected biological factors.
Patients will have 5 ml of venous blood drawn twice (before and after completing the study) to perform the blood test.
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From enrollment to the end of treatment at 12 weeks
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Outcomes in patients suffering from schizophrenia - MOCA or ACE-III or CSSS Scale.
기간: From enrollment to the end of treatment at 12 weeks
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1. Cognitive function testing using the MOCA or ACE-III or the CSSS Scale. The MOCA or ACE-III scales are described above in the outcomes in patients suffering from schizophrenia requiring institutional care group. The Cognitive Screening Scale for Schizophrenia (CSSS) is a brief diagnostic tool used to quickly detect cognitive deficits in people with schizophrenia. This scale assesses the patient's overall cognitive performance, is time-consuming, and aids in qualifying patients for rehabilitation. Higher scores indicate better cognitive functioning. |
From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia - PSYRATS
기간: From enrollment to the end of treatment at 12 weeks
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The intensity of positive or negative symptoms is assessed using the PSYRATS Psychotic Symptom Rating Scale and the BNSS (Brief Negative Syndrome Scale). -The PSYRATS Scale (Psychotic Symptom Rating Scale) is a multidimensional tool for the assessment of auditory hallucinations and delusions, consisting of two subscales (for hallucinations and delusions) rated from 0 to 4. Scale Structure: Auditory Hallucinations Subscale (AHS): contains 11 questions, including questions about frequency, duration, loudness, content, degree of distress, and belief in the reality of voices. Delusions Subscale (DS): contains 6 questions, including questions about the degree of preoccupation, belief in reality, and anxiety. Assessment Method: Each symptom feature (dimension) is scored on a scale from 0 (no symptom) to 4 (maximum severity). |
From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia - BNSS
기간: From enrollment to the end of treatment at 12 weeks
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The intensity of positive or negative symptoms is assessed using the BNSS (Brief Negative Syndrome Scale). -The Brief Negative Symptom Scale (BNSS) is a clinical tool used to assess the severity of symptoms in schizophrenia. Its basic information and structure consist of 13 questions divided into 6 main subscales. The test format: a semi-structured patient interview combined with clinical observation. Duration: approximately 15 minutes. Scoring range: 0 (no symptom) to 6 (extreme severity) for each item; the total score ranges from 0 to 78 points. |
From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia - Emotional state examination
기간: From enrollment to the end of treatment at 12 weeks
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Emotional state examination, which will be carried out by determining the degree of:
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia - INTE
기간: From enrollment to the end of treatment at 12 weeks
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Emotional intelligence testing with the INTE Emotional Intelligence Questionnaire. The INTE questionnaire measures emotional intelligence, defined as the ability to recognize, understand, and control one's own and others' emotions, as well as the ability to effectively use emotions to guide one's own and others' actions. It is primarily used for research purposes. The survey lasts approximately 10 minutes. Sum of item values give a total emotional intelligence metric. |
From enrollment to the end of treatment at 12 weeks
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outcomes in patients suffering from schizophrenia - blood test
기간: From enrollment to the end of treatment at 12 weeks
|
Description: Blood concentration testing for selected biological factors.
Patients will have 5 ml of venous blood drawn twice (before and after completing the study) to perform the blood test.
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From enrollment to the end of treatment at 12 weeks
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outcomes in patients (women) addicted to alcohol MOCA or ACE-III
기간: From enrollment to the end of treatment at 6 weeks.
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1. Cognitive function testing using the MOCA or ACE-III diagnostic tools The Montreal Cognitive Assessment (MOCA) and the Addenbrooke's Cognitive Examination-III (ACE-III) are key medical tests used to find cognitive impairment. Cognitive function testing using the MOCA or ACE-III - The Montreal Cognitive Assessment (MOCA) assesses cognitive function. The test consists of 30 tasks assessing language, memory, reasoning, orientation, visual reasoning, and spatial reasoning. The test takes approximately 10-15 minutes to complete. Maximum score: 30 points. One point is added for individuals with less than 12 years of education. - The Addenbrooke's Cognitive Examination III (ACE-III) is an extended screening tool for cognitive function. The test assesses attention and orientation, memory, verbal fluency, language, and visuospatial functions. The test takes approximately 15 minutes. The maximum score is 100 points. A score below 88 suggests the presence of cognitive impairment. |
From enrollment to the end of treatment at 6 weeks.
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outcomes in patients (women) addicted to alcohol - Emotional state
기간: From enrollment to the end of treatment at 6 weeks.
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Emotional state examination, which will be carried out by determining the degree of severity of depressive symptoms using the BDI or GDS or CES-D scale (The Center for Epidemiologic Studies Depression Scale). The Beck Depression Inventory (BDI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Geriatric Depression Scale (GDS) are three widely used self-report tools to screen for and measure the severity of depressive symptoms. |
From enrollment to the end of treatment at 6 weeks.
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outcomes in patients (women) addicted to alcohol - Anxiety levels - Burns Anxiety Inventory
기간: From enrollment to the end of treatment at 6 weeks
|
Anxiety levels using the Burns Anxiety Inventory Burns Anxiety Inventory The questionnaire consists of 33 questions divided into three main categories, which the patient rates based on their experience over the past week: Anxious feelings - 6 items (e.g., nervousness, sense of impending doom, panic attacks).
Anxious thoughts - 11 items (e.g., fear of losing control, fear of going crazy or becoming physically ill).
Physical symptoms - 16 items (e.g., heart palpitations, dizziness, muscle tension, shortness of breath).
Scoring: Each of the 33 questions is rated on a 4-point Likert scale from 0 to 3 points: 0 - Not at all / did not bother 1 - A little / slightly 2 - Moderate 3 - Very much.
The total score ranges from 0 to 99 points.
Interpretation of results: 0-4 points: Minimal or no anxiety, 5-10 points: Anxiety very mild, 11-20 points: Mild anxiety, 21-30 points: Moderate anxiety, 31-50 points: Severe anxiety.
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From enrollment to the end of treatment at 6 weeks
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outcomes in patients (women) addicted to alcohol - Anxiety levels - STAI
기간: From enrollment to the end of treatment at 6 weeks.
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Emotional state examination, which will be carried out by determining the degree of: b. Anxiety levels using the Burns Anxiety Inventory or STAI State-Trait Anxiety Inventory. The STAI (State-Trait Anxiety Inventory) measures two distinct types of anxiety: State Anxiety (the X-1 scale for temporary feelings) and Trait Anxiety (long-term feelings). The STAI is a tool for assessing anxiety, understood as a transient and situationally determined individual state, and anxiety, understood as a relatively stable personality trait. It is used for screening and individual assessment; the X-1 scale is also useful in experimental studies requiring the recording of changes in anxiety intensity. |
From enrollment to the end of treatment at 6 weeks.
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outcomes in patients (women) addicted to alcohol - CISS
기간: From enrollment to the end of treatment at 6 weeks.
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Emotional state examination, which will be carried out by determining the degree of CISS (Coping Inventory for Stressful Situations) Scale. A questionnaire for diagnosing stress coping styles. It is used for research and practical purposes, for example, as a tool in qualification tests for specific job positions in certain professions (police, firefighters, drivers), or in testing individuals applying for firearms licenses. In our study, we aim to determine whether Snoezelen therapy can influence the stress coping style of women addicted to alcohol. Rating Scale: A 5-point frequency scale ranging from 1 ("not at all") to 5 ("very much"). |
From enrollment to the end of treatment at 6 weeks.
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outcomes in patients (women) addicted to alcohol - SWLS
기간: From enrollment to the end of treatment at 6 weeks.
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Emotional state examination, which will be carried out by determining the degree of: - Satisfaction with life using the SWLS scale. Life satisfaction using the SWLS scale The SWLS (Satisfaction with Life Scale) is a short psychological tool used to assess overall life satisfaction. It consists of five statements, which the respondent rates on a seven-point scale. It is intended for adults, both healthy and sick, and takes approximately two minutes to complete. The scasle contains five statements regarding satisfaction with one's overall life. Response Format: Seven-point Likert scale (from 1 - I completely disagree to 7 - I completely agree). Score: overall life satisfaction index = the higher the score, the greater the sense of satisfaction. |
From enrollment to the end of treatment at 6 weeks.
|
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outcomes in patients (women) addicted to alcohol - INTE
기간: From enrollment to the end of treatment at 6 weeks.
|
Emotional intelligence testing with the INTE Emotional Intelligence Questionnaire. The INTE questionnaire measures emotional intelligence, defined as the ability to recognize, understand, and control one's own and others' emotions, as well as the ability to effectively use emotions to guide one's own and others' actions. It is primarily used for research purposes. The survey lasts approximately 10 minutes. Sum of item values give a total emotional intelligence metric. |
From enrollment to the end of treatment at 6 weeks.
|
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outcomes in patients (women) addicted to alcohol - blood test
기간: From enrollment to the end of treatment at 6 weeks.
|
Blood concentration testing for selected biological factors.
Patients will have 5 ml of venous blood drawn twice (before and after completing the exercise) to perform the blood test.
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From enrollment to the end of treatment at 6 weeks.
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outcomes in patients (women) addicted to alcohol - follow up PACS Scale
기간: 4 weeks after the end of study (follow-up), a telephone interview will be conducted with the use of short Penn Alcohol Craving Scale (PACS).
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* 4 weeks after the end of study (follow-up), a telephone interview will be conducted with the use of short Penn Alcohol Craving Scale (PACS). The Scale is a self-assessment method, it comprises 5 statements, and is designed to assess alcohol craving experienced by a patient in a week prior to the examination. 0-3 points - low intensity of alcohol craving, 4-9 points - average intensity of alcohol craving, above 10 points - high intensity of alcohol craving. |
4 weeks after the end of study (follow-up), a telephone interview will be conducted with the use of short Penn Alcohol Craving Scale (PACS).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laura Piejko, PT, PhD, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Resolution no. 02-IX/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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