The Effect of Psychological State on Post Spinal Puncture Headache and Backache

NCT03427372 | Completed DMC

• 1 other identifier: post dural puncture headache
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• post spinal puncture headache (PDPH)

  For assessing PDPH, patients will ask whether they experienced headache through the use of a dichotomous scale (yes or no answer). The severity of PDPH will be assessed by the Dittmann's scale. This PDPH specific scale was composed of 4 levels of severity. Level 1 indicated minimal PDPH with no use of medications to manage PDPH with the patient able to participate in daily living activities without any inferences. Level 2 indicated mild PDPH that required the use of analgesics with patients still able to engage in daily living activities. Level 3 indicated moderate PDPH where analgesic administration was required to control the level of pain. Level 4 indicated severe PDPH with an epidural blood patch recommended.

  one week after surgery

Secondary Outcomes (3)

• anxiety

  fifteen minutes before spinal anesthesia

• depression

  fifteen minutes before spinal anesthesia

• post spinal puncture backache (PDPB)

  one week after surgery

Study Arms (4)

group 1: patients with headache

the patients who have post spinal puncture headache after spinal anesthesia

Behavioral: anxiety scale, depression scale

group 2: patients without headache

the patients who do not have post spinal puncture headache after spinal anesthesia

Behavioral: anxiety scale, depression scale

group 3: patients with backache

the patients who have post spinal puncture backache after spinal anesthesia

group 4: patients without backache

the patients who do not have post spinal puncture backache after spinal anesthesia

Interventions

anxiety scale, depression scale BEHAVIORAL

post spinal puncture headache and backache will be assess by using visual analogue scale, anxiety will assess by beck anxiety scale, depression mood will assess by beck depression scale

group 1: patients with headache; group 2: patients without headache

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18-80 years old American Society of Anesthesiology (ASA) I-III patients underwent spinal anesthesia

You may qualify if:

• patient scehedule surgery under spinal anesthesia
• between 18-80 years old

You may not qualify if:

• patients with psychiatric disorders

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Ahi evran university education and research hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (1)

• Peker K, Polat R. The effects of preoperative reactions of emotional distress on headache and acute low back pain after spinal anesthesia: A prospective study. J Psychosom Res. 2021 May;144:110416. doi: 10.1016/j.jpsychores.2021.110416. Epub 2021 Mar 11.

  PMID: 33735647 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• kevser peker

  Ahi Evran University Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 9, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

TU (1)