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

September 30, 2019 updated by: Kevser Peker, Ahi Evran University Education and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one week after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
anxiety
Time Frame: fifteen minutes before spinal anesthesia
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
Time Frame: fifteen minutes before spinal anesthesia
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)
Time Frame: one week after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahi Evran University Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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