The Experience of Loneliness Among Patients During the Perioperative Period

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01203761
First received: September 1, 2010
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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.

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.

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.

Loneliness 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.

The 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.


Condition
Anxiety
Depression

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Experience of Loneliness Among Ear, Nose and Throat (ENT) Surgical Patients During the Perioperative Period

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Loneliness [ Time Frame: One day before surgery until POD3 ] [ Designated as safety issue: No ]
    Qualitative evaluation of the loneliness experience


Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preoperative patients
ENT surgical patients, approximately 1 day before their procedure undertaken
Postoperative patients
ENT surgical patients during their postoperative hospitalization
Family members
Family members of ENT surgical patients, during the perioperative period

Detailed Description:

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].

From 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].

Despite 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.

Loneliness 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].

Study 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.

The 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population includes 3 groups:

  1. ENT surgical patients in the preoperative period
  2. ENT surgical patients in the postoperative period
  3. Family members of ENT patients, perioperatively
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Emergency procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203761

Contacts
Contact: Ami Rokach, Mr. 972542020405 rokach.ami@gmail.com

Locations
Israel
Tel Aviv Sourasky medical center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Ami Rokach    972542020405    rokach.ami@gmail.com   
Contact: Idit Matot, Professor    97236974758    iditm@tasmc.health.gov.il   
Sub-Investigator: Yifat Klein, PhD         
Principal Investigator: Idit Matot, MD         
Sub-Investigator: Ami Rokach, Mr.         
Sub-Investigator: Orit Arkobi, Ms.         
Sub-Investigator: Kauter Natur, Ms.         
Sub-Investigator: Dan Fliss, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Chair: Idit Matot, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Professor Idit Matot. Chair, Department of Anesthsiology & Intensive Care, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01203761     History of Changes
Other Study ID Numbers: TASMC-10-IM-0301-CTIL
Study First Received: September 1, 2010
Last Updated: September 15, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
loneliness

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 24, 2014