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

The Effect of Anxiety and Depression Mood on Post Spinal Puncture Headache and Backache

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

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: anxiety scale, depression scale

Detailed Description

Before spinal anesthesia patients' anxiety and depression mood will recorded with Beck anxiety and Beck depression scale fifteen minute before spinal anesthesia.Seven days after surgery post spinal puncture headache and backache will assess by a telephonic interview

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• Turkey
  • Kırşehir, Turkey
    • Ahi Evran University Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients with psychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1: patients with headache; the patients who have post spinal puncture headache after spinal anesthesia	Behavioral: anxiety scale, depression scale; 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 2: patients without headache; the patients who do not have post spinal puncture headache after spinal anesthesia	Behavioral: anxiety scale, depression scale; 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety	Anxiety will evaluated by the Beck Anxiety Inventory (BAI), which consists of 21 questions about how the individual has felt in the preceding week regarding common anxiety symptoms, such as sweating, tremor, fear, and feelings of distress. The cutoff point for anxiety is 12, and scores between 1 and 11 are considered subsyndromal anxiety.	fifteen minutes before spinal anesthesia
depression	Depression will assess by beck depression scale. The Beck Depression Scale (BDS) uses a 3-point Likert type response scale to 21 questions. In the scale, a total of 0-13 points are considered 'normal', 14-25 points to indicate 'depression', and 26-63 points to indicate'severe depression'.	fifteen minutes before spinal anesthesia
post spinal puncture backache (PDPB)	The presence of backache will asses by using visual analogue scale (VAS). Patients will familiarized with 10 cm marked VAS for assessment of back pain, where 0 cm defines no pain, and 10 cm defines the maximum intolerable pain	one week after surgery

Collaborators and Investigators

• Sponsor: Ahi Evran University Education and Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: February 3, 2018
• First Submitted That Met QC Criteria: February 3, 2018
• First Posted (ACTUAL): February 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pain; Neurologic Manifestations; Depression; Headache
• Other Study ID Numbers: post dural puncture headache

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No