ClinicalTrials.gg
CompletedNCT03427372Updated Oct 2, 2019

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

An observational study in Depression, Anxiety, sponsored by Ahi Evran University Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by Ahi Evran University Education and Research Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
370
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 340 studies in Depression with a site in Turkey — 59 open to participants now, 70 under way, none of them phase 3. Depression · Turkey.

Enrollment
11th of 96
370 · median 105
Started
2018
with 11 others
Observational
96 of 340
16 open now
Registered
12th of 340
by date

Among the 340 studies in Depression with a site in Turkey, this one is the 11th largest by enrollment of the 96 observational ones that give a count, is one of 12 that started in 2018, is one of 96 observational ones, and was the 12th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

59 of the 340 studies in Depression with a site in Turkey are open now. Recruiting first, the newest first:

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All 59 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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

03

Conditions studied

  • Depression, Anxiety
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with psychiatric disorders
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
370 participants (actual)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • Behavioralanxiety 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

06

What researchers measure

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.

    Time frame: one week after surgery

Secondary outcomes

  1. 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.

    Time frame: fifteen minutes before spinal anesthesia

  2. 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'.

    Time frame: fifteen minutes before spinal anesthesia

  3. 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

    Time frame: one week after surgery

07

Study locations

1 site
  • Ahi evran university education and research hospital
    Kırşehir, Turkey
08

References and documents

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. PubMed 33735647 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Oct 2018, 1 month.

Of 460 non-industry observational studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's 1 month is below that.

Counting every sponsor, half of 493 studies reached it within 32 months; a quarter within 13 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2018
First posted
Feb 9, 2018
StartActual
Sep 1, 2018
Primary completionActual
Oct 1, 2018
CompletionActual
Oct 1, 2018
Last update
Oct 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03427372
Lead sponsor
Ahi Evran University Education and Research Hospital
Responsible party
Kevser Peker (MD, Ahi Evran University Education and Research Hospital) — Principal investigator
First posted
Feb 9, 2018
Start date
Sep 1, 2018
Primary completion
Oct 1, 2018
Completion
Oct 1, 2018
Last update
Oct 2, 2019

Study contacts

kevser peker
principal investigator · Ahi Evran University Education and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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