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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427372
• Other study ID #: post dural puncture headache
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2019
• Source: Ahi Evran University Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patient scehedule surgery under spinal anesthesia

• between 18-80 years old

Exclusion Criteria:

• patients with psychiatric disorders

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Depressive Disorder
• Headache

Intervention

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

Locations

Country	Name	City	State
Turkey	Ahi evran university education and research hospital	Kirsehir

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evran University Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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