Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-28 @ 10:34 AM
Study NCT ID:
NCT01203761
Status:
UNKNOWN
Last Update Posted:
2010-09-16
First Post:
2010-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Experience of Loneliness Among Patients During the Perioperative Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-09-15', 'studyFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loneliness', 'timeFrame': 'One day before surgery until POD3', 'description': 'Qualitative evaluation of the loneliness experience'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['loneliness'], 'conditions': ['Anxiety', 'Depression']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '(1) Hughes B. Psychology, hospitalization and some thoughts on medical training. European Journal of Psychotherapy and Counselling 2001;4: 7-26. (2) Ernst JM CJ. Lonely Hearts: Psychological perspectives on loneliness. Applied and Preventative Psychology 1999;8: 1-22. (3) McWhirter B. Loneliness: A review of current literature with implications for counselling and research. Journal of Counselling and Development 1990;68: 417-423. (4) Davis HH, R Edson, C Ziegler. The relationship between optimism-pessimism, loneliness, and levels of self-esteem in college students. College Student Journal 1992;26: 244-247. (5) Booth R BD, Bohnsock J An examination of the relationship between happiness, loneliness, and shy men in college students. Journal of College Student Development 1992;33: 157-162. (6) Riggio RE WK, Throckmorton B. Social skills, social support, and psychosocial adjustment. Personality and Individual Differences 1993;15: 275-308.'}]}, 'descriptionModule': {'briefSummary': "The experience of illness and hospitalization exerts a great deal of psychological distress, one of the most distressful events people might experience throughout their life times. Surgery and anesthesia with their accompanying loss of control, fear of being unconscious and invaded, and expectation of postoperative pain adds appreciably to that stress and anxiety.\n\nCurrent psycho-physiological research has provided evidence on the alarming possibility of the aversive affects of hospitalization stress on the patients' already deteriorated physical health and marked interference with their recovery.\n\nAs an additional stressor, which may partly be related to the hospital staff, and partly to the person's illness and expected surgery is loneliness.\n\nLoneliness is a painful experience that is, commonly, not embraced and which has consequences that are detrimental to one's emotional, physical and spiritual well being.\n\nThe present study explores the qualitative aspects of loneliness (via questionnaires) in two patient populations: (1) patients facing surgery, and (2) patients who have already undergone surgery. In addition, family members \\[i.e. those waiting outside of the operating room\\] will be given a questionnaire, and these three groups will be compared to the general population.", 'detailedDescription': "The modern hospital environment is generally perceived to provide a safe and healing environment for people inflicted with a variety of illnesses, be it for short term visits and minor health problems or more serious conditions requiring long term treatment and care. However, the experience of illness and hospitalization nonetheless exerts a great deal of psychological distress, one of the most distressful events people might actually experience in their life time \\[1\\].\n\nFrom the outset, illness itself is a major stressor on one's life. However, surgery, with its accompanying loss of control, fear of being invaded, and expectation of post operative pain adds appreciably to that stress and anxiety. Current psycho-physiological research has provided evidence on the alarming possibility of the aversive affects of hospitalization stress on the patients' already deteriorated physical health and marked interference with their recovery \\[1\\].\n\nDespite the best intentions of most hospital staffs, emotional distance and depersonalization of the patients might be their natural reaction in dealing with the harsh reality of the patients' ill fate and enormous demands of their responsibilities without being burned out or losing their focus of attention on treatment tasks. As an additional stressor, which may partly be related to the hospital staff, and partly to the person's illness and expected surgery is Loneliness.\n\nLoneliness is a painful experience that is, commonly, not embraced and which has consequences that are detrimental to one's emotional, physical and spiritual well being \\[2,3\\]. Lonely individuals tend to exhibit negative intrapersonal traits like pessimism \\[2,4\\]. Loneliness was found to be negatively correlated with happiness \\[5\\] and life satisfaction \\[6\\]. It has been linked to such maladies as depression, hostility, alcoholism, poor self-concept, and psychosomatic illnesses \\[3\\].\n\nStudy design The present study will explore the qualitative aspects of loneliness \\[not its intensity\\] in two patient populations: (1) patients facing surgery, and (2) patients who have already undergone surgery. In addition, family members \\[i.e. those waiting outside of the operating room\\] will be given a questionnaire, and these three groups will be compared to the general population.\n\nThe loneliness questionnaire is a 60 item yes/no questionnaire that will examine the quality of the loneliness that the participant may experience (enclosed with the proposal). Additionally, there will be demographic questions, and information will be sought about the illness of the patient, the number of hospitalization days, and previous hospitalizations or surgeries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes 3 groups:\n\n1. ENT surgical patients in the preoperative period\n2. ENT surgical patients in the postoperative period\n3. Family members of ENT patients, perioperatively', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 y/o) inpatients of American Society of Anesthesiologists (ASA) I-IV physical statuses, undergoing an elective surgery at the Ear, Nose and Throat (ENT) department of Tel Aviv Sourasky medical center.\n\nExclusion Criteria:\n\n* Emergency procedures.'}, 'identificationModule': {'nctId': 'NCT01203761', 'briefTitle': 'The Experience of Loneliness Among Patients During the Perioperative Period', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Experience of Loneliness Among Ear, Nose and Throat (ENT) Surgical Patients During the Perioperative Period', 'orgStudyIdInfo': {'id': 'TASMC-10-IM-0301-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative patients', 'description': 'ENT surgical patients, approximately 1 day before their procedure undertaken'}, {'label': 'Postoperative patients', 'description': 'ENT surgical patients during their postoperative hospitalization'}, {'label': 'Family members', 'description': 'Family members of ENT surgical patients, during the perioperative period'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'Ami Rokach', 'role': 'CONTACT', 'email': 'rokach.ami@gmail.com', 'phone': '972542020405'}, {'name': 'Idit Matot, Professor', 'role': 'CONTACT', 'email': 'iditm@tasmc.health.gov.il', 'phone': '97236974758'}, {'name': 'Yifat Klein, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Idit Matot, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ami Rokach, Mr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Orit Arkobi, Ms.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kauter Natur, Ms.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dan Fliss, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tel Aviv Sourasky medical center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Ami Rokach, Mr.', 'role': 'CONTACT', 'email': 'rokach.ami@gmail.com', 'phone': '972542020405'}], 'overallOfficials': [{'name': 'Idit Matot, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Professor Idit Matot. Chair, Department of Anesthsiology & Intensive Care', 'oldOrganization': 'Tel-Aviv Sourasky Medical Center'}}}}