NCT01203761

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

September 1, 2010

Last Update Submit

September 15, 2010

Conditions

Keywords

loneliness

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    Qualitative evaluation of the loneliness experience

    One day before surgery until POD3

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Emergency procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • (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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Idit Matot, MD

    Tel-Aviv Sourasky Medical Center

    STUDY CHAIR

Central Study Contacts

Ami Rokach, Mr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 16, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations