AnxietyNCT01203761
The Experience of Loneliness Among Patients During the Perioperative Period
An observational study of Anxiety and Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Emergency procedures.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky medical center
Tel Aviv, 64239
Ami Rokach, 972542020405, rokach.ami@gmail.com
Idit Matot, Professor, 97236974758, iditm@tasmc.health.gov.il
About this study
Official title: The Experience of Loneliness Among Ear, Nose and Throat (ENT) Surgical Patients During the Perioperative Period
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.
Read more
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.
Read the 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.
- Conditions
- Anxiety, Depression
- Keywords
- loneliness
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
Qualitative evaluation of the loneliness experience
Measured: One day before surgery until POD3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Idit Matot, MD, Study chair, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203761
- Sponsor's protocol ID
- TASMC-10-IM-0301-CTIL
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2010
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
(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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Loneliness Among Ear, Nose and Throat (ENT) Surgical Patients During the Perioperative Period
- ClinicalTrials.gov ID
- NCT01203761
- Acronym / sponsor ID
- TASMC-10-IM-0301-CTIL
- Conditions
- Anxiety, Depression
- Keywords
- loneliness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Emergency procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Loneliness
Time frame: One day before surgery until POD3
Qualitative evaluation of the loneliness experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
- Background(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.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit Matot, MD study chair
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ami Rokach, Mr. (972542020405, rokach.ami@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: One day before surgery until POD3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.