Depression, AnxietyNCT03427372
The Effect of Psychological State on Post Spinal Puncture Headache and Backache
An observational study of Depression, Anxiety, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- anxiety scale, depression scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 370 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Oct 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-80 years old American Society of Anesthesiology (ASA) I-III patients underwent spinal anesthesia
Who may be able to join
- patient scehedule surgery under spinal anesthesia
- between 18-80 years old
Who cannot join
- patients with psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi evran university education and research hospital
Kırşehir
About this study
Official title: 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
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
- Conditions
- Depression, Anxiety
- Being tested
- anxiety scale, depression scale
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anxiety scale, depression scaleBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| group 1: patients with headache | the patients who have post spinal puncture headache after spinal anesthesia Receives: Behavioral: anxiety scale, depression scale | |
| group 2: patients without headache | the patients who do not have post spinal puncture headache after spinal anesthesia Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week after surgery
Secondary outcomes (3)
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.
Measured: 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'.
Measured: 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
Measured: one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Sep 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Peker, Ahi Evran University Education and Research Hospital
- Investigators
- kevser peker, Principal investigator, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427372
- Sponsor's protocol ID
- post dural puncture headache
- Status last verified
- Sep 2019
- First submitted
- 3 Feb 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anxiety and Depression Mood on Post Spinal Puncture Headache and Backache
- ClinicalTrials.gov ID
- NCT03427372
- Acronym / sponsor ID
- post dural puncture headache
- Conditions
- Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1: patients with headache | – | Behavioral: anxiety scale, depression scalethe patients who have post spinal puncture headache after spinal anesthesia |
| group 2: patients without headache | – | Behavioral: anxiety scale, depression scalethe patients who do not have post spinal puncture headache after spinal anesthesia |
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-80 years old American Society of Anesthesiology (ASA) I-III patients underwent spinal anesthesia
Key inclusion criteria (2 listed)
- patient scehedule surgery under spinal anesthesia
- between 18-80 years old
Key exclusion criteria (1 listed)
- patients with psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anxiety scale, depression scalepost 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 | Behavioural | group 1: patients with headache, group 2: patients without headache |
Primary outcome
post spinal puncture headache (PDPH)
Time frame: one week after surgery
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.
3 secondary outcomes
anxiety
Time frame: fifteen minutes before spinal anesthesia
depression
Time frame: fifteen minutes before spinal anesthesia
post spinal puncture backache (PDPB)
Time frame: one week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 33735647Peker 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kevser peker principal investigator
Ahi Evran University Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post spinal puncture headache (PDPH) (time frame: one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.